AzTrials
AzTrials

Pancreatic AdenocarcinomaPhase 3NCT01013649

Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery

A Phase 3 study testing 3-Dimensional Conformal Radiation Therapy, Biospecimen Collection and Capecitabine in people with Pancreatic Adenocarcinoma and Pancreatic Ductal Adenocarcinoma, run by National Cancer Institute (NCI) at 689 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
3-Dimensional Conformal Radiation Therapy, Biospecimen Collection and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
546 participants
Where
689 sitesin 4 countries
Study dates
5 Apr 2010to 4 Sep 2025
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e., removal of all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy; patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible
  • The operating surgeon must document in the operative note that a complete gross excision of the primary tumor was achieved; the pathology report must include documentation of the margin status and the size of the tumor; the pathology report must also include the status of the three major margins-bile duct, pancreatic parenchyma, and retroperitoneal (uncinate)
  • For patients who have not started their chemotherapy prior to registration, the interval between definitive tumor-related surgery and 1st step registration must be between 21-70 days; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, the interval between definitive tumor-related surgery and day one of adjuvant chemotherapy must be between 21-77 days
  • Patients will be staged according to the 6th edition American Joint Committee on Cancer (AJCC) staging system with pathologic stage T1-3, N0-1, M-0 being eligible. Pathologic reporting using the College of American Pathologists (CAPS) format is strongly encouraged
  • Age >= 18
  • Zubrod performance status 0 or 1
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  • Complete history and physical examination including weight and Zubrod status within 31 days of study entry (or within 31 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
  • Before starting therapy the patient should be able to maintain adequate oral nutrition of >= 1500 calories estimated caloric intake per day and be free of significant nausea and vomiting
  • Complete blood count (CBC)/differential obtained within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelets >= 100,000/mm^3
  • Hemoglobin >= 8.0 g/dL (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
  • Post resection serum cancer antigen (CA)19-9 =< 180 units/mL AND prior to any systemic treatment
  • Serum total bilirubin =< twice the institutional upper limit of normal (ULN) within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
  • Creatinine levels =< twice the institutional upper limit of normal within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
  • Serum glutamic oxaloacetic transaminase (SGOT) must be =< 2.5 x the institutional upper limit of normal within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
  • Negative serum pregnancy test for women of childbearing potential within 14 days of study registration
  • Abdominal/pelvic CT scan with contrast is preferred; abdominal CT alone is acceptable only if insurance restrictions are experienced; chest CT/x-ray (CT of chest preferred) within 31 days of registration on study (or within 31 days prior to day 1 of chemo post-surgery for those patients having started chemotherapy prior to first step registration); patients allergic to IV contrast can have MRI of the abdomen/pelvis instead
  • Signed study-specific informed consent
  • Consultation, agreement, and documentation in the patient's chart by a radiation oncologist that patient is suitable to receive radiotherapy per this protocol
  • Women of childbearing potential and male participants must practice adequate contraception
  • Patients with active human immunodeficiency virus (HIV) infection are eligible if their cluster of differentiation (CD)4 count is > 499/cu mm and their viral load is < 50 copies/ml; use of highly active antiretroviral treatment (HAART) is allowed

Who cannot join

  • Patients with non-adenocarcinomas, adenosquamous carcinomas, islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas; patients with tumors that are largely intraductal papillary mucinous neoplasms (IPMN) with a minimal or minor component of invasive carcinoma are not eligible; patients with acinar carcinomas are not eligible; patients with IPMN's that contain some secondary (minor) foci of adenocarcinoma are also not eligible
  • Patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy
  • Patients entering on the study after pancreaticoduodenectomy, who have not already started chemotherapy must not have had prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, patients must not have received adjuvant chemotherapy with agents other than gemcitabine, nab-paclitaxel, oxaliplatin, fluoropyrimidine, or irinotecan for the current pancreatic cancer; prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Previous history of invasive malignancy (except non-melanoma skin cancer) unless the patient has been disease free for at least 2 years prior to study entry (or first day of chemotherapy for patients having started chemotherapy prior to first step registration); patients with a previous history of carcinoma in situ are eligible
  • Severe, active co-morbidity, defined as follows per time points indicated below (or per time points indicated below prior to the first day of chemotherapy for patients having started chemotherapy prior to first step registration):
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  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the 3 months of study registration
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Pregnant or lactating women
  • Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
  • If surgical margin status cannot be determined after consultation with the operating surgeon and the institutional pathologist, the patient will be ineligible

Trial locations and contacts

689 sites in 4 countries.

311 sites in 4 countries

United States300 sites

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • New York Oncology Hematology PC - Albany

    Albany, New York, 12206

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Radiation Oncology Center

    Alliance, Ohio, 44601

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • Texas Oncology-Arlington South

    Arlington, Texas, 76014

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

  • Texas Oncology-Austin Midtown

    Austin, Texas, 78705

  • Texas Oncology - Central Austin Cancer Center

    Austin, Texas, 78731

  • Texas Oncology - South Austin Cancer Center

    Austin, Texas, 78745

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Summa Health System - Barberton Campus

    Barberton, Ohio, 44203

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Texas Oncology Bedford

    Bedford, Texas, 76022

  • Franciscan Saint Francis Health-Beech Grove

    Beech Grove, Indiana, 46107

  • Overlake Medical Center

    Bellevue, Washington, 98004

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59102

  • OSF Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Boulder Community Foothills Hospital

    Boulder, Colorado, 80303

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Toledo Clinic Cancer Centers-Bowling Green

    Bowling Green, Ohio, 43402

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Hartford HealthCare - Saint Vincent's Medical Center

    Bridgeport, Connecticut, 06606

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Sands Cancer Center

    Canandaigua, New York, 14424

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University Charleston Division

    Charleston, West Virginia, 25304

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Atrium Health Pineville/LCI-Pineville

    Charlotte, North Carolina, 28210

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • Presence Resurrection Medical Center

    Chicago, Illinois, 60631

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

  • Community Cancer Institute

    Clovis, California, 93611

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Columbus NCI Community Oncology Research Program

    Columbus, Ohio, 43215

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Huron Valley-Sinai Hospital

    Commerce, Michigan, 48382

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023-1291

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Delaware Radiation Oncology

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Texas Oncology - Denison Cancer Center

    Denison, Texas, 75020

  • AdventHealth Porter

    Denver, Colorado, 80210

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • Saint Joseph Hospital - Cancer Centers of Colorado

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Western States Cancer Research NCORP

    Denver, Colorado, 80222

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa-Wide Oncology Research Coalition NCORP

    Des Moines, Iowa, 50309

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Epic Care-Dublin

    Dublin, California, 94568

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Easton Hospital

    Easton, Pennsylvania, 18042

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • OSF Saint Francis Hospital and Medical Group

    Escanaba, Michigan, 49829

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Saint Anne's Hospital

    Fall River, Massachusetts, 02721

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Texas Oncology-Flower Mound

    Flower Mound, Texas, 75028

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Radiation Oncology Associates PC

    Fort Wayne, Indiana, 46804

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805

  • Texas Oncology - Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Fredericksburg Oncology Inc

    Fredericksburg, Virginia, 22401

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Fresno Cancer Center

    Fresno, California, 93720

  • Saint Agnes Medical Center

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610

  • Northeast Georgia Medical Center-Gainesville

    Gainesville, Georgia, 30501

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Tacoma/Valley Radiation Oncology Centers-Gig Harbor

    Gig Harbor, Washington, 98332

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • Mountain Blue Cancer Care Center

    Golden, Colorado, 80401

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Nebraska Cancer Specialists/Oncology Hematology West PC

    Grand Island, Nebraska, 68803

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Banner North Colorado Medical Center

    Greeley, Colorado, 80631

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Marin General Hospital

    Greenbrae, California, 94904

  • East Carolina University

    Greenville, North Carolina, 27834

  • Greenville Health System Cancer Institute-Andrews

    Greenville, South Carolina, 29601

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Rocky Mountain Cancer Centers-Greenwood Village

    Greenwood Village, Colorado, 80111

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Sentara Cancer Institute at Sentara CarePlex Hospital

    Hampton, Virginia, 23666

  • WellSpan Medical Oncology and Hematology

    Hanover, Pennsylvania, 17331

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

  • Oncology Las Vegas - Henderson

    Henderson, Nevada, 89074

  • AdventHealth Hendersonville

    Hendersonville, North Carolina, 28792

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • Memorial Hermann Memorial City Medical Center

    Houston, Texas, 77024

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Beacon Kalamazoo

    Kalamazoo, Michigan, 49048

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • Presence Saint Mary's Hospital

    Kankakee, Illinois, 60901

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Heartland Hematology and Oncology Associates Incorporated

    Kansas City, Missouri, 64118

  • Research Medical Center

    Kansas City, Missouri, 64132

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • ECU Health Oncology Kinston

    Kinston, North Carolina, 28501

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Lancaster Radiation Oncology

    Lancaster, Ohio, 43130

  • Carolina Blood and Cancer Care Associates PA-Lancaster

    Lancaster, South Carolina, 29720

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Cancer and Blood Specialists-Shadow

    Las Vegas, Nevada, 89106

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

  • GenesisCare USA - Las Vegas

    Las Vegas, Nevada, 89109

Other trials in United States

Belgium4 sites

  • Hospital Univ. Erasme

    Brussels, 1070

  • University Hospital Saint Luc

    Brussels, 1200

  • Algemeen Ziekenhuis Groeninge Campus Kennedylaan

    Kortrijk, 8500

  • AZ Turnhout-Campus Saint Elizabeth

    Turnhout, 2300

Other trials in Belgium

Canada4 sites

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • Ottawa Hospital and Cancer Center-General Campus

    Ottawa, Ontario, K1H 8L6

  • Ottawa Hospital-Civic Campus

    Ottawa, Ontario, K1Y 4E9

Other trials in Canada

Israel3 sites

  • Rabin Medical Center

    Petah Tikva, 49100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Chaim Sheba Medical Center

    Tel Litwinsky, 52621

Other trials in Israel

About this study

Official title: A Phase II-R and a Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients With Resected Head of Pancreas Adenocarcinoma

This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine whether the addition of erlotinib (erlotinib hydrochloride) to gemcitabine (gemcitabine hydrochloride) adjuvant chemotherapy shows a signal for improved survival as compared to gemcitabine alone following R0 or R1 resection of head of pancreas adenocarcinoma (including adenocarcinoma of the head, neck, and uncinate process). (Phase II-R) II. To determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine based chemotherapy or non-gemcitabine based chemotherapy such as modified fluorouracil-leucovorin-irinotecan-oxaliplatin regimen (FOLFIRINOX) further enhances survival for such patients who are without evidence of progressive disease after 5 months of adjuvant chemotherapy. (Phase III)

SECONDARY OBJECTIVES:

  1. To evaluate disease-free survival of adjuvant chemotherapy followed by radiotherapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after 5 months of adjuvant chemotherapy.

II. To evaluate disease-free survival of standard adjuvant gemcitabine chemotherapy with and without erlotinib for patients with resected head of pancreas adenocarcinoma.

III. To evaluate adverse events with and without erlotinib for patients with resected head of pancreas adenocarcinoma.

IV. To evaluate adverse events of adjuvant chemotherapy with or without radiation therapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after adjuvant chemotherapy.

  1. To evaluate preoperative cross-sectional imaging of the primary head of pancreas adenocarcinoma in order to determine the frequency with which objective criteria of resectability are present.

VI. To determine if patients reporting low baseline fatigue, as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, predicts survival and to explore correlations between baseline fatigue, as measured by Patient-Reported Outcomes Measurement Information System (PROMIS), and survival.

OUTLINE: Patients without disease progression after treatment in arm I or II are randomized to 1 of 2 additional treatment arms (arm III or IV).

ARM I: Patients receive either gemcitabine hydrochloride or allowable combination chemotherapy per standard of care for 5 months.

ARM II (closed to accrual 4/2/14): Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride orally (PO) once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive the same treatment as in arm I for 1 month.

ARM IV: Patients receive the same treatment as in arm I for 1 month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO twice daily (BID) 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed.

Patients undergo computed tomography (CT), magnetic resonance imaging (MRI), and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.

After completion of study treatment, patients are followed up every 3-6 months for up to 4 years, then yearly.

Being tested
3-Dimensional Conformal Radiation Therapy, Biospecimen Collection, Capecitabine, Chemotherapy, Computed Tomography
Medical subject headings
Pancreatic Intraductal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3-Dimensional Conformal Radiation TherapyRadiation

    Also called 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT

    Undergo 3-dimensional conformal radiation therapy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood and tissue sample collection

  • CapecitabineDrug

    Also called Ro 09-1978/000, Xeloda

    Given PO

  • ChemotherapyDrug

    Also called Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General

    Given combination chemotherapy

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Erlotinib HydrochlorideDrug

    Also called CP 358, CP-358, Cp-358,774, CP358

    Given PO

  • FluorouracilDrug

    Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione

    Given IV

  • Gemcitabine HydrochlorideDrug

    Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar

    Given IV

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo intensity-modulated radiation therapy

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • X-Ray ImagingProcedure or surgery

    Also called Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs

    Undergo x-ray imaging

Study groups in NCT01013649
Study groupRoleWhat they receive
Arm I (gemcitabine hydrochloride or combination chemotherapy)Active comparatorPatients receive either gemcitabine hydrochloride or allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
Receives: Procedure: Biospecimen Collection; Drug: Chemotherapy; Procedure: Computed Tomography; Drug: Gemcitabine Hydrochloride; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Procedure: X-Ray Imaging
Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)ExperimentalPatients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline. (closed to accrual 4/2/14)
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Erlotinib Hydrochloride; Drug: Gemcitabine Hydrochloride; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Procedure: X-Ray Imaging
Arm III (chemotherapy)ExperimentalPatients receive the same treatment as in arm I for 1 month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
Receives: Procedure: Biospecimen Collection; Drug: Chemotherapy; Procedure: Computed Tomography; Drug: Gemcitabine Hydrochloride; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Procedure: X-Ray Imaging
Arm IV (chemotherapy, chemoradiotherapy)ExperimentalPatients receive the same treatment as in arm I for 1 month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Procedure: Biospecimen Collection; Drug: Capecitabine; Drug: Chemotherapy; Procedure: Computed Tomography; Drug: Fluorouracil; Drug: Gemcitabine Hydrochloride; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Procedure: X-Ray Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (Percentage of Participants Alive) [Phase II]

    Overall survival is estimated by the Kaplan-Meier method. Survival time is measured from step 1 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur after 200 deaths were reported.

    Measured: From step 1 randomization (gemcitabine vs. gemcitabine/erlotinib) to death or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years.

  2. Overall Survival (Percentage of Participants Alive) [Phase III]

    Overall survival (OS) is estimated by the Kaplan-Meier method. Survival time is measured from step 2 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all patients have five years potential follow-up from step 2 randomization.

    Measured: From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to the date of death or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.

Secondary outcomes (5)

  1. Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase II]

    Disease-free survival is estimated by the Kaplan-Meier method. Disease-free survival time is measured from step 1 randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to any cause, or last known follow-up (censored). Analysis was to occur after 200 deaths were reported.

    Measured: From step1 randomization (gemcitabine vs. gemcitabine/erlotinib) to disease event, death, or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years. Five-year rates are reported here.

  2. Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase III]

    Disease-free survival is estimated by the Kaplan-Meier method. Disease-free survival time is measured from step 2 randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to any cause, or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all participants have five years potential follow-up from second step randomization.

    Measured: From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to disease event, death, or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.

  3. Number of Participants by Highest Grade Adverse Event Reported (Phase II)

    Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 which grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

    Measured: From step 1 randomization (gemcitabine vs. gemcitabine/erlotinib) to death or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years.

  4. Number of Participants by Highest Grade Adverse Event Reported (Phase III)

    Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 which grades adverse event severity from 1=mild to 5=death.

    Measured: From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to death or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.

  5. Overall Survival (Percentage of Participants Alive) by Baseline Fatigue Group

    Overall survival is estimated by the Kaplan-Meier method. Survival time is measured from enrollment (step 1) to date of death from any cause or last known follow-up (censored). Baseline fatigue is measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACT-F) questionnaire which has a range of 0 to 52 with a higher score indicating less fatigue. Combining treatment arms, patients with low fatigue at baseline (FACIT-F score > 30) will be compared to patients with high fatigue at baseline (FACIT-F scores ≤ 30).

    Measured: From enrollment (step 1) to death or last follow-up. Maximum follow-up at time of the phase III analysis was 13.2 years, measured from enrollment. Two- and five-year rates are reported here.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2009 (estimated)
  2. Study start5 Apr 2010
  3. Primary completion10 Dec 2023
  4. Study completion4 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
546 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01013649
Sponsor's protocol ID
NCI-2011-01987
Other IDs
NCI-2011-01987, 11-00773, CDR0000659092, RTOG 0848, RTOG-0848, RTOG-0848, U10CA021661, U10CA180830
Status last verified
Feb 2026
First submitted
13 Nov 2009
Last updated
23 Feb 2026
Data monitoring committee
No

Publications

  • Abrams RA, Winter KA, Goodman KA, Regine WF, Safran HP, Guha CS, Kachnic LA, Gillin MT, Philip PA, Lowy AM, O'Reilly E, Van Laethem JL, Seaward SA, Wu AJ, Wu JJ, Aljumaily RM, DiPetrillo TA, Geva R, Anne PR, Liles DK, Ling DC, Conlin A, Moughan J, Crane CH. Adjuvant Chemotherapy +/- Chemoradiotherapy for Adenocarcinoma of the Pancreatic Head: Results of the Radiotherapy Random Assignment of NRG Oncology/RTOG 0848. J Clin Oncol. 2026 Aug 20;44(24):2316-2328. doi: 10.1200/JCO-25-02520. Epub 2026 Jun 9.

    PubMed 42456089

  • Jethwa KR, Kim E, Berlin J, Anker CJ, Tchelebi L, Abood G, Hallemeier CL, Jabbour S, Kennedy T, Kumar R, Lee P, Sharma N, Small W Jr, Williams V, Russo S. Executive Summary of the American Radium Society Appropriate Use Criteria for Neoadjuvant Therapy for Nonmetastatic Pancreatic Adenocarcinoma: Systematic Review and Guidelines. Am J Clin Oncol. 2024 Apr 1;47(4):185-199. doi: 10.1097/COC.0000000000001076. Epub 2023 Dec 22.

    PubMed 38131628

  • Tchelebi LT, Winter KA, Abrams RA, Safran HP, Regine WF, McNulty S, Wu A, Du KL, Seaward SA, Bian SX, Aljumaily R, Shivnani A, Knoble JL, Crocenzi TS, DiPetrillo TA, Roof KS, Crane CH, Goodman KA. Analysis of Radiation Therapy Quality Assurance in NRG Oncology RTOG 0848. Int J Radiat Oncol Biol Phys. 2024 Jan 1;118(1):107-114. doi: 10.1016/j.ijrobp.2023.08.014. Epub 2023 Aug 19.

    PubMed 37598723

  • Conroy T, Lambert A, Ducreux M. Adjuvant and neoadjuvant approaches in pancreatic cancer. Curr Opin Oncol. 2023 Jul 1;35(4):326-333. doi: 10.1097/CCO.0000000000000962. Epub 2023 May 12.

    PubMed 37222189

  • Batukbhai B, Herman JM, Zahurak M, Laheru DA, Le DT, Wolfgang CL, Zheng L, De Jesus-Acosta A. Survival Outcomes of Adjuvant Chemotherapy Combined With Radiation Versus Chemotherapy Alone After Pancreatectomy for Distal Pancreatic Adenocarcinoma: A Single-Institution Experience. Pancreas. 2021 Jan 1;50(1):64-70. doi: 10.1097/MPA.0000000000001724.

    PubMed 33370024

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