AzTrials
AzTrials

Lung CancerPhase 3NCT00632853

Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

A Phase 3 study testing Standard Radiation Dose Therapy, cisplatin and etoposide in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 934 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

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Standard Radiation Dose Therapy, cisplatin and etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
731 participants
Where
934 sitesin 4 countries
Study dates
Mar 2008to 15 Apr 2026
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
  1. Documentation of Disease
  2. Histologically or cytologically documented small cell lung cancer (SCLC)
  3. Limited-stage disease patients with disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes
  • Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes are not eligible
  • Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not are not eligible unless they have a negative thoracentesis
  • Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray are not eligible
  1. Measurable disease - Patients must have measurable disease, which includes lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques OR ≥ 1 cm by spiral CT scan
  2. Prior Treatment
  3. Patients may have received one and only one cycle of chemotherapy prior to enrolling on CALGB 30610, which must have included carboplatin or cisplatin and etoposide.
  4. If a patient has had one cycle of cisplatin or carboplatin/etoposide prior to registration, the patient must have had all of it prior to registration tests as outlined in the protocol and prior to starting their first cycle of chemotherapy.
  5. Additionally, these patients also must have met all of the eligibility criteria in the protocol prior to receiving the first cycle of chemotherapy.
  6. Registration to CALGB 30610 must take place within 14-21 days after the start of the non-protocol therapy.
  7. Failing to do all of the above will make the patient NOT eligible for CALGB 30610.
  8. No prior radiotherapy or chemotherapy (except for the chemotherapy described in the bullet above) for SCLC
  9. No prior mediastinal or thoracic radiotherapy
  10. Patients with complete surgical resection of disease are not eligible
  11. Age Requirement ≥ 18 years of age
  12. ECOG Performance Status 0-2
  13. Non-pregnant and non-nursing - No patients that are known to be pregnant or nursing
  14. Required Initial Laboratory Values
  15. Granulocytes ≥ 1,500/µl
  16. Platelet count ≥ 100,000/µl
  17. Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  18. AST (SGOT) ≤ 2.0 times ULN
  19. Serum creatinine ≤ 1.5 times ULN OR Calculated creatinine clearance ≥ 70 mL/min

Trial locations and contacts

934 sites in 4 countries.

304 sites in 4 countries

United States300 sites

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • AdventHealth Altamonte

    Altamonte Springs, Florida, 32701

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Cancer Care Center at Island Hospital

    Anacortes, Washington, 98221

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Regional Hospital

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • Ascension Saint Elizabeth Hospital

    Appleton, Wisconsin, 54915

  • PCR Oncology

    Arroyo Grande, California, 93420

  • Cancer Care of Western North Carolina

    Asheville, North Carolina, 28801

  • Mission Hospital

    Asheville, North Carolina, 28801

  • Mountain Radiation Oncology PA

    Asheville, North Carolina, 28801

  • AdventHealth Infusion Center Asheville

    Asheville, North Carolina, 28803

  • Hope Women's Cancer Centers-Asheville

    Asheville, North Carolina, 28816

  • 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

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • Saint Alphonsus Medical Center-Baker City

    Baker City, Oregon, 97814

  • AIS Cancer Center at San Joaquin Community Hospital

    Bakersfield, California, 93301

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Veterans Administration Medical Center-Baltimore

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • 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

  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, 70805

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70806

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Ochsner Health Center-Summa

    Baton Rouge, Louisiana, 70809

  • Our Lady of the Lake Physicians Group - Medical Oncology

    Baton Rouge, Louisiana, 70809

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • Baptist Hospitals of Southeast Texas Cancer Center

    Beaumont, Texas, 77701

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • Swedish Cancer Institute-Eastside Oncology Hematology

    Bellevue, Washington, 98005

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • The Kirklin Clinic at Acton Road

    Birmingham, Alabama, 35243

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Saint Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • 21st Century Oncology - Bradenton

    Bradenton, Florida, 34210

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • Transylvania Regional Hospital

    Brevard, North Carolina, 28712

  • United Hospital Center

    Bridgeport, West Virginia, 26330

  • Steward Saint Elizabeth's Medical Center

    Brighton, Massachusetts, 02135

  • IHA Hematology Oncology Consultants-Brighton

    Brighton, Michigan, 48114

  • Saint Joseph Mercy Brighton

    Brighton, Michigan, 48114

  • Wellmont Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • Wellmont Medical Associates Oncology and Hematology-Bristol

    Bristol, Tennessee, 37620

  • Wellmont Medical Associates-Bristol

    Bristol, Virginia, 24201

  • Ascension Southeast Wisconsin Hospital - Elmbrook Campus

    Brookfield, Wisconsin, 53045

  • Crozer-Keystone Regional Cancer Center at Broomall

    Broomall, Pennsylvania, 19008

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Veterans Affairs Western New York Health Care System-Buffalo

    Buffalo, New York, 14215

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Sands Cancer Center

    Canandiaqua, New York, 14424

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • IHA Hematology Oncology Consultants-Canton

    Canton, Michigan, 48188

  • Saint Joseph Mercy Canton

    Canton, Michigan, 48188

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Southeast Missouri Hospital

    Cape Girardeau, Missouri, 63701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Caro Cancer Center

    Caro, Michigan, 48723

  • Tanner Medical Center/Carrollton

    Carrollton, Georgia, 30117

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Geauga Hospital

    Chardon, Ohio, 44024

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University Charleston Division

    Charleston, West Virginia, 25304

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Oncology Specialists of Charlotte

    Charlotte, North Carolina, 28207

  • Southern Oncology Specialists-Charlotte

    Charlotte, North Carolina, 28262

  • Memorial Hospital

    Chattanooga, Tennessee, 37404

  • IHA Hematology Oncology Consultants-Chelsea

    Chelsea, Michigan, 48118

  • Saint Joseph Mercy Chelsea

    Chelsea, Michigan, 48118

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • 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

  • University of Cincinnati/Barrett Cancer 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

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • 21st Century Oncology MHP - Clarkston

    Clarkston, Michigan, 48346

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Community Cancer Institute

    Clovis, California, 93611

  • University Oncology Associates

    Clovis, California, 93611

  • Big Horn Basin Cancer Center

    Cody, Wyoming, 82414

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

  • 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

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384

  • Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Northshore Oncology Associates-Covington

    Covington, Louisiana, 70433

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023-1291

  • Dayton Veterans Affairs Medical Center

    Dayton, Ohio, 45428

  • Beaumont Hospital - Dearborn

    Dearborn, Michigan, 48124

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Heartland Cancer Research NCORP

    Decatur, Illinois, 62526

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Delaware Radiation Oncology

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • National Jewish Health-Main Campus

    Denver, Colorado, 80206

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • University of Colorado

    Denver, Colorado, 80217-3364

  • 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

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Mercy Capitol

    Des Moines, Iowa, 50307

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Kaiser Permanente Dublin

    Dublin, California, 94568

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Southwest Oncology PC

    Durango, Colorado, 81301

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Great Lakes Cancer Management Specialists-Doctors Park

    East China, Michigan, 48054

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Memorial Sloan Kettering Westchester

    East White Plains, New York, 10604

  • University of Maryland Shore Medical Center at Easton

    Easton, Maryland, 21601

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • 21st Century Oncology - El Segundo

    El Segundo, California, 90245

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Arnot Ogden Medical Center/Falck Cancer Center

    Elmira, New York, 14905

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • Ephrata Community Hospital

    Ephrata, Pennsylvania, 17522

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49829

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Saint Francis Hospital

    Evanston, Illinois, 60202

  • Deaconess Clinic Downtown

    Evansville, Indiana, 47713

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Exeter Hospital

    Exeter, New Hampshire, 03833

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • 21st Century Oncology MHP - Farmington

    Farmington Hills, Michigan, 48334

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Beaumont Hospital - Farmington Hills

    Farmington Hills, Michigan, 48336

  • Simonds-Sinon Regional Cancer Center

    Fitchburg, Massachusetts, 01420

  • Genesee Cancer and Blood Disease Treatment Center

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Saint Agnes Hospital/Agnesian Cancer Center

    Fond du Lac, Wisconsin, 54935

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • 21st Century Oncology - Fort Walton Beach

    Fort Walton Beach, Florida, 32547

  • Radiation Oncology Associates PC

    Fort Wayne, Indiana, 46804

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805

  • Parkview Regional Medical Center

    Fort Wayne, Indiana, 46845

  • Angel Medical Center

    Franklin, North Carolina, 28734

  • Ascension Saint Francis - Reiman Cancer Center

    Franklin, Wisconsin, 53132

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Fresno Cancer Center

    Fresno, California, 93720

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Mountain States Tumor Institute - Fruitland

    Fruitland, Idaho, 83619

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Northeast Georgia Medical Center-Gainesville

    Gainesville, Georgia, 30501

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

Other trials in United States

Puerto Rico2 sites

  • San Juan Community Oncology Group

    San Juan, 00917

  • San Juan City Hospital

    San Juan, 00936

Other trials in Puerto Rico

Israel1 site

  • Rabin Medical Center

    Petah Tikva, 49100

Other trials in Israel

South Korea1 site

  • Yonsei University Health System-Severance Hospital

    Seoul, 120-752

Other trials in South Korea

About this study

Official title: Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.

Read the detailed description

OUTLINE: This is a 2-part, multicenter, randomized study. Patients are stratified according to gender, weight loss 6 months prior to study entry (≤ 5% of body weight vs > 5% of body weight), ECOG performance status (0 vs 1 vs 2), radiotherapy technique (intensity-modulated radiotherapy vs 3-dimensional conformal radiotherapy), radiotherapy start time (at first cycle of protocol chemotherapy, after one cycle of prior non-protocol chemotherapy vs at first cycle of protocol chemotherapy, without prior non-protocol chemotherapy vs at second cycle of protocol chemotherapy, without prior non-protocol chemotherapy) and chemotherapy backbone: carboplatin vs cisplatin.

OBJECTIVES:

Primary Objective

To determine whether administering high dose thoracic radiotherapy, 70 Gy (2 Gy once-daily over 7 weeks) or 61.2 Gy (1.8 Gy once-daily for 16 days followed by 1.8 Gy twice-daily for 9 days), will improve median and 2-year survival compared with 45 Gy (1.5 Gy twice-daily over 3 weeks) in patients with limited stage small cell lung cancer.

Secondary Objectives

  1. To compare treatment related toxic effects of thoracic radiotherapy regimens in patients with limited stage small cell lung cancer
  2. To compare response rates, failure-free survival and toxicity of thoracic radiotherapy regimens in patients with limited stage small cell lung cancer
  3. To compare rates of local relapse, distant metastases and brain metastases with these regimens
  4. To compare patients' quality of life between these treatment regimens in terms of their physical symptoms, physical functioning and psychological state
  5. To describe the patterns of use of thoracic intensity modulated radiation therapy (IMRT) in patients with limited stage small cell lung cancer
  6. To examine blood-based biomarkers of response and resistance to cisplatin (or carboplatin) and etoposide
  7. To evaluate the correspondence between increases in plasma ProGRP concentrations and disease progression/recurrence
  8. To evaluate the potential for plasma ProGRP concentrations at baseline, after each cycle of chemotherapy and at first evaluation following completion of chemotherapy to predict PFS and OS
  9. To evaluate the correspondence between longitudinal decreases in plasma ProGRP concentrations and clinical response

Part 1: Patients are randomized to 1 of 3 treatment arms.

Arm I: Patients undergo standard-dose (45 Gy given in 30 treatments) thoracic radiotherapy twice daily, 5 days a week, for 3 weeks. Patients also receive cisplatin IV on day 1 or carboplatin IV and etoposide IV on days 1, 2, and 3.

Arm II: Patients undergo higher-dose (70 Gy given in 35 treatments) thoracic radiotherapy once daily, 5 days a week, for 7 weeks. Patients also receive cisplatin or carboplatin and etoposide as in arm I.

Arm III: (discontinued as of 03/10/13) Patients undergo mid-dose (61.2 Gy given in 34 treatments) thoracic radiotherapy once daily, 5 days a week, during the initial 16 days (approximately 3 weeks) of treatment and then twice daily, 5 days a week, for the final 9 days (approximately 2 weeks) of treatment. Patients also receive cisplatin and etoposide.

In all arms, treatment with cisplatin and etoposide repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Part 2: An interim analysis was conducted after accrual of 30 patients per arm and one experimental arm based upon a comparison of treatment-related toxicity was selected. The most toxic experimental arm was discontinued, and the trial continues comparing standard therapy (arm I) to the selected experimental regimen (arm II) as described in part 1. Please see the Arms section for more information regarding Part 2.

Prophylactic cranial irradiotherapy (PCI): Within 3-6 weeks after completion of chemotherapy, PCI should be offered to all patients with a complete tumor response (CR) or near complete response (nCR) with only residual chest abnormalities of indeterminate nature following completion of combined modality therapy.

After completion of study treatment, patients are followed up at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years or until disease progression. At disease progression, patients are followed up every 6 months.

Conditions
Lung Cancer
Being tested
Standard Radiation Dose Therapy, cisplatin, etoposide, High Radiation Dose Therapy, carboplatin
Keywords
limited stage small cell lung cancer
Medical subject headings
Lung Neoplasms

What participants receive

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

Study groups in NCT00632853
Study groupRoleWhat they receive
Arm A - Standard Radiotherapy + ChemotherapyActive comparatorRadiotherapy (every day, Monday-Friday, for a total of 3 weeks) XRT: 45 Gy BID (1.5 Gy/fx) starting on day 1 of Cycle 1 or 2, every day, for 3 weeks Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks): * Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days * Etoposide 100 mg/m2 IV Register/ on days 1, 2, and 3, every 21 days
Receives: Radiation: Standard Radiation Dose Therapy; Drug: cisplatin; Drug: etoposide; Drug: carboplatin
Arm B - High Dose Radiotherapy + ChemotherapyExperimentalRadiotherapy (every day, Monday-Friday, for a total of 7 weeks) XRT: 70 Gy QD (2.0 Gy/fx), starting on day 1 of Cycle 1 or 2, every day, for 7 weeks Chemotherapy (every 21 days for 4 cycles, for a total of 12 weeks): * Cisplatin 80 mg/m2 IV on day 1 OR Carboplatin AUC 5 IV day 1, every 21 days * Etoposide 100 mg/m2 IV on days 1, 2, and 3, every 21 days
Receives: Drug: cisplatin; Drug: etoposide; Radiation: High Radiation Dose Therapy; Drug: carboplatin

What is being measured

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

  1. Overall Survival Time

    Overall survival time is defined as the time between a patient's registration and death or end of survival follow up.

    Measured: 11.25 years

Secondary outcomes (9)

  1. Complete and Partial Response Rates

    Measured: 11.25 years

  2. Failure-free>> Survival

    Measured: Up to 5 years

  3. To Compare Rates of Local Relapse, Distant Metastases and Brain Metastases With These > Regimens.

    Measured: 5 years

  4. To Compare Patients' Quality of Life Between These Treatment Regimens in Terms of Their > Physical Symptoms, Physical Functioning and Psychological State.

    Measured: 5 years

  5. To Describe the Patterns of Use of Thoracic Intensity Modulated Radiation Therapy (IMRT) in Patients With Limited Stage Small Cell Lung Cancer.

    Measured: 5 years

  6. To Examine Blood-based Biomarkers of Response and Resistance to Cisplatin (or Carboplatin) and Etoposide.

    Measured: 5 years

  7. To Evaluate the Correspondence Between Increases in Plasma ProGRP Concentrations and Disease Progression/Recurrence

    Measured: 5 years

  8. To Evaluate the Potential for Plasma ProGRP Concentrations at Baseline, After Each Cycle of > Chemotherapy and at First Evaluation Following Completion of Chemotherapy to Predict PFS and OS.

    Measured: 5 years

  9. To Evaluate the Correspondence Between Longitudinal Decreases in Plasma ProGRP Concentrations and Clinical Response.

    Measured: 5 years

Timeline

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

  1. First posted11 Mar 2008 (estimated)
  2. Study startMar 2008
  3. Primary completion2 Mar 2022
  4. Study completion15 Apr 2026

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
731 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00632853
Sponsor's protocol ID
CALGB-30610
Other IDs
CALGB-30610, RTOG 0538, U10CA031946, CDR0000588879, NCI-2009-00470
Status last verified
May 2026
First submitted
8 Mar 2008
Last updated
10 Sep 2026
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Farris MK, Mix MD, Wang X, Jaszewski B, Foster N, Masters GA, Laurie F, Smith K, Razavian NB, Alden RS, Komaki R, Stinchcombe TE, Bradley JD, Vokes EE, Bogart J. Prognostic Factors in Limited-Stage Small Cell Lung Cancer: A Secondary Analysis of CALGB 30610-RTOG 0538. JAMA Netw Open. 2024 Oct 1;7(10):e2440673. doi: 10.1001/jamanetworkopen.2024.40673.

    PubMed 39446327

  • Bogart J, Wang X, Masters G, Gao J, Komaki R, Gaspar LE, Heymach J, Bonner J, Kuzma C, Waqar S, Petty W, Stinchcombe TE, Bradley JD, Vokes E. High-Dose Once-Daily Thoracic Radiotherapy in Limited-Stage Small-Cell Lung Cancer: CALGB 30610 (Alliance)/RTOG 0538. J Clin Oncol. 2023 May 1;41(13):2394-2402. doi: 10.1200/JCO.22.01359. Epub 2023 Jan 9.

    PubMed 36623230

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