AzTrials
AzTrials

Esophageal CancerPhase 3NCT00655876

Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer

A Phase 3 study testing cetuximab, cisplatin and paclitaxel in people with Esophageal Cancer, run by Radiation Therapy Oncology Group at 175 sites in 2 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

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

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Esophageal Cancer
What is being tested?
cetuximab, cisplatin and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
344 participants
Where
175 sitesin 2 countries
Study dates
Jun 2008to 20 May 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically (histologic or cytologic) proven diagnosis of primary squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction within 12 weeks prior to registration. Patients with involvement of the gastroesophageal junction with Siewert type I or II tumors (tumors arising from the distal esophagus and involving the esophagogastric junction or tumors starting at the esophagogastric junction and involving the cardia) are eligible.
  • 1.1 Disease must be encompassed in a radiotherapy field.
  • 1.2 Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible.
  • 1.3 Patients with cervical esophageal carcinoma are eligible.
  • Stage T1N1M0; T2-4, Any N, M0; Any T, Any N, M1a, based upon the following minimum diagnostic work-up:
  • 2.1 History/physical examination within 6 weeks prior to registration
Show all 23Show fewer
  • 2.2 Positron emission tomography (PET)/positron emission tomography-computed tomography (PET-CT) scan (strongly recommended) or chest/abdominal CT within 6 weeks prior to registration
  • 2.3 Electrocardiogram (EKG) within 6 weeks of study entry
  • 2.4 Endoscopy with biopsy or cytology by fine needle aspiration (FNA) (must be able to document histologic subtype) within 12 weeks of study entry. Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo bronchoscopy to exclude fistula. (NOTE: Any images from endoscopic procedures up to the time of progression must be kept in the patient's confidential study file.)
  • Zubrod performance status 0-2
  • Age ≥ 18 and ≤ 74 (upper limit was set at 74 in an amendment)
  • Complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:
  • 5.1 Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
  • 5.2 Platelets ≥ 100,000 cells/mm3
  • 5.3 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥8.0 g/dl is acceptable.)
  • Additional laboratory studies obtained within 2 weeks prior to registration on study
  • 6.1 Creatinine ≤ 1.5 mg/dl
  • 6.2 Bilirubin ≤ 1.5 x upper limit of normal
  • 6.3 Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
  • 6.4 Serum pregnancy test for women of childbearing potential
  • Patient's total intake (oral/enteral) must be ≥ 1500 kCal/day
  • Patient must provide study-specific informed consent prior to study entry
  • Women of childbearing potential and male participants must practice adequate contraception

Who cannot join

  • Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi. Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo bronchoscopy to exclude fistula.
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  • Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a different cancer is allowable.
  • Prior radiation therapy that would result in overlap of planned radiation therapy fields.
  • Prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway.
  • Prior platinum-based and/or paclitaxel-based therapy.
Show all 16Show fewer
  • Prior allergic reaction to the study drugs involved in this protocol.
  • Prior severe infusion reaction to a monoclonal antibody.
  • Severe, active comorbidity, defined as follows:
  • 9.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months
  • 9.2 Transmural myocardial infarction within the last 6 months
  • 9.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • 9.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • 9.5 Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients.
  • Pregnancy or 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.
  • Women who are nursing.

Trial locations and contacts

175 sites in 2 countries.

175 sites in 2 countries

United States173 sites

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • New York Oncology Hematology, PC at Albany Regional Cancer Care

    Albany, New York, 12206

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Saint John's Cancer Center at Saint John's Medical Center

    Anderson, Indiana, 46016

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Auburn Radiation Oncology

    Auburn, California, 95603

  • Rocky Mountain Cancer Centers - Aurora

    Aurora, Colorado, 80012

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center Cancer Center

    Baltimore, Maryland, 21204

  • St. Agnes Hospital Cancer Center

    Baltimore, Maryland, 21229

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • UPMC Cancer Center at Beaver Medical Center

    Beaver, Pennsylvania, 15009

  • Texas Oncology, PA at Harris Center HEB

    Bedford, Texas, 76022

  • MeritCare Bemidji

    Bemidji, Minnesota, 56601

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Lourdes Regional Cancer Center

    Binghamton, New York, 13905

  • Bloomington Hospital Regional Cancer Institute

    Bloomington, Indiana, 47403

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Alamance Cancer Center at Alamance Regional Medical Center

    Burlington, North Carolina, 27216

  • Radiation Oncology Centers - Cameron Park

    Cameron Park, California, 95682

  • Mercy Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Aultman Cancer Center at Aultman Hospital

    Canton, Ohio, 44710-1799

  • Cancer Institute of Cape Girardeau, LLC

    Cape Girardeau, Missouri, 63703

  • Mercy Cancer Center at Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Enloe Cancer Center at Enloe Medical Center

    Chico, California, 95926

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • UPMC Cancer Center at Jefferson Regional Medical Center

    Clairton, Pennsylvania, 15025

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • MetroHealth Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Payson Center for Cancer Care at Concord Hospital

    Concord, New Hampshire, 03301

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Texas Oncology, PA at Texas Cancer Center - Denton South

    Denton, Texas, 76210

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Seacoast Cancer Center at Wentworth - Douglass Hospital

    Dover, New Hampshire, 03820

  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Regional Cancer Center - Erie

    Erie, Pennsylvania, 16505

  • Willamette Valley Cancer Center - Eugene

    Eugene, Oregon, 97401

  • Center for Cancer Care at Exeter Hospital

    Exeter, New Hampshire, 03833

  • Hudner Oncology Center at Saint Anne's Hospital - Fall River

    Fall River, Massachusetts, 02721

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Radiation Oncology Associates Southwest

    Fort Wayne, Indiana, 46804

  • Parkview Regional Cancer Center at Parkview Health

    Fort Wayne, Indiana, 46805

  • Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital

    Fort Worth, Texas, 76104

  • California Cancer Center - Woodward Park Office

    Fresno, California, 93720

  • Saint Agnes Cancer Center at Saint Agnes Medical Center

    Fresno, California, 93720

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Charles R. Wood Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • UPMC Cancer Center - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • Cancer Centers of the Carolinas - Faris Road

    Greenville, South Carolina, 29605

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Hawaii Medical Center - East

    Honolulu, Hawaii, 96817

  • Memorial Hermann Hospital - Memorial City

    Houston, Texas, 77024

  • Methodist Cancer Center at Methodist Hospital

    Indianapolis, Indiana, 46202

  • Central Indiana Cancer Centers - East

    Indianapolis, Indiana, 46219

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Kingsbury Center for Cancer Care at Cheshire Medical Center

    Keene, New Hampshire, 03431

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Center for Cancer Care and Research at Watson Clinic, LLP

    Lakeland, Florida, 33805

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • Longview Cancer Center

    Longview, Texas, 75601

  • James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

  • Elliot Regional Cancer Center at Elliot Hospital

    Manchester, New Hampshire, 03103

  • Minnesota Oncology - Maplewood

    Maplewood, Minnesota, 55109

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Mercy Cancer Center at Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Lake/University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Southwest General Health Center

    Middleburg Heights, Ohio, 44130

  • Veterans Affairs Medical Center - Milwaukee

    Milwaukee, Wisconsin, 53295

  • Memorial Medical Center

    Modesto, California, 95355

  • Cancer Center at Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

    New Britain, Connecticut, 06050

  • Beth Israel Medical Center - Petrie Division

    New York, New York, 10003-3803

  • St. Luke's - Roosevelt Hospital Center - St.Luke's Division

    New York, New York, 10025

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • William W. Backus Hospital

    Norwich, Connecticut, 06360

  • Regional Cancer Center at Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Lakeside Hospital

    Omaha, Nebraska, 68130

  • UHHS Chagrin Highlands Medical Center

    Orange, Ohio, 44122

  • M.D. Anderson Cancer Center at Orlando

    Orlando, Florida, 32806

  • Advocate Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068-1174

  • Frankford Hospital Cancer Center - Torresdale Campus

    Philadelphia, Pennsylvania, 19114

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • UPMC - Shadyside

    Pittsburgh, Pennsylvania, 15213-2582

  • UPMC Cancer Center at UPMC St. Margaret

    Pittsburgh, Pennsylvania, 15215

  • UPMC Cancer Center at UPMC Passavant

    Pittsburgh, Pennsylvania, 15237

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Rhode Island Hospital Comprehensive Cancer Center

    Providence, Rhode Island, 02903

  • Northmain Radiation Oncology

    Providence, Rhode Island, 02904

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Robinson Radiation Oncology

    Ravenna, Ohio, 44266

  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Swedish-American Regional Cancer Center

    Rockford, Illinois, 61104-2315

  • Radiation Oncology Center - Roseville

    Roseville, California, 95661

  • Radiological Associates of Sacramento Medical Group, Incorporated

    Sacramento, California, 95815

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Mercy General Hospital

    Sacramento, California, 95819

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • Cancer Care Centers of South Texas - Northeast

    San Antonio, Texas, 78217

  • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

    Savannah, Georgia, 31405

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

  • Cancer Centers of the Carolinas - Seneca

    Seneca, South Carolina, 29672

  • Texas Oncology, PA at Texas Cancer Center - Sherman

    Sherman, Texas, 75090

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

    Sleepy Hollow, New York, 10591

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Frederick R. and Betty M. Smith Cancer Treatment Center

    Sparta, New Jersey, 07871

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Centers of the Carolinas - Spartanburg

    Spartanburg, South Carolina, 29307

  • Cancer Institute at St. John's Hospital

    Springfield, Illinois, 62702

  • Saint Louis University Cancer Center

    St Louis, Missouri, 63110

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • Door County Cancer Center at Door County Memorial Hospital

    Sturgeon Bay, Wisconsin, 54235-1495

  • Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land

    Sugar Land, Texas, 77479

  • J. Phillip Citta Regional Cancer Center at Community Medical Center

    Toms River, New Jersey, 08755

  • Arizona Oncology - Tucson

    Tucson, Arizona, 85704

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Solano Radiation Oncology Center

    Vacaville, California, 95687

  • Sutter Solano Medical Center

    Vallejo, California, 94589

  • Northwest Cancer Specialists at Vancouver Cancer Center

    Vancouver, Washington, 98684

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Waukesha Memorial Hospital Regional Cancer Center

    Waukesha, Wisconsin, 53188

  • University of Wisconcin Cancer Center at Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401

  • UHHS Westlake Medical Center

    Westlake, Ohio, 44145

  • Schiffler Cancer Center at Wheeling Hospital

    Wheeling, West Virginia, 26003

  • Texas Oncology, PA - Wichita Falls

    Wichita Falls, Texas, 76310

  • York Cancer Center at Apple Hill Medical Center

    York, Pennsylvania, 17405

Other trials in United States

Canada2 sites

  • McGill Cancer Centre at McGill University

    Montreal, Quebec, H2W 1S6

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

Other trials in Canada

About this study

Official title: A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may stop the growth of esophageal cancer by blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin together with radiation therapy is more effective with or without cetuximab in treating esophageal cancer.

PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate whether the addition of cetuximab to chemotherapy comprising paclitaxel, cisplatin, and radiotherapy improves overall survival compared with paclitaxel, cisplatin, and radiotherapy alone in patients with esophageal cancer treated without surgery.

Secondary

  • To evaluate whether the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy improves local control by increasing the clinical complete response and decreasing local recurrence in these patients.
  • To evaluate adverse events in these patients.
  • To evaluate endoscopic complete response rates in these patients.
  • To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy improves the Esophageal Cancer Subscale (ECS) score of the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) quality of life tool.
  • To evaluate the quality-adjusted survival of each treatment arm using EQ-5D if the primary endpoint supports the primary hypothesis.

OUTLINE: This is a multicenter study. Patients are stratified according to histology (adenocarcinoma vs squamous), cancer lesion size (< 5 cm vs ≥ 5 cm), and disease status of celiac nodes (present vs absent). Patients are randomized to 1 of 2 treatment arms.

Being tested
cetuximab, cisplatin, paclitaxel, radiation therapy
Keywords
stage IIA esophageal cancer, stage IIB esophageal cancer, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer, stage IV esophageal cancer, squamous cell carcinoma of the esophagus
Medical subject headings
Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma

What participants receive

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

  • cetuximabDrug

    Weekly with external beam radiation therapy for a total of six doses. The initial dose of cetuximab is 400 mg/m^2 intravenously administered over 120 minutes on day 1, followed by weekly infusions of 250 mg/m^2 intravenously over 60 minutes on days 8, 15, 22, 29, and 36. The infusion rate of cetuximab must never exceed 5 mL/min.

  • cisplatinDrug

    Weekly with external beam radiation therapy for a total of six doses. Patients receive 25 mg/m^2 as an intravenous infusion over 30-60 minutes on days 1, 8, 15, 22, 29 and 36.

  • paclitaxelDrug

    Weekly with external beam radiation therapy for a total of six doses. Patients receive 50 mg/m^2 as an intravenous infusion over 1 hour on days 1, 8, 15, 22, 29 and 36.

  • radiation therapyRadiation

    1.8 Gy daily for 28 days (over 5-6 weeks) for a total dose of 50.4 Gy.

Study groups in NCT00655876
Study groupRoleWhat they receive
Chemoradiation + CetuximabExperimentalExternal beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
Receives: Drug: cetuximab; Drug: cisplatin; Drug: paclitaxel; Radiation: radiation therapy
ChemoradiationActive comparatorExternal beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
Receives: Drug: cisplatin; Drug: paclitaxel; Radiation: radiation therapy

What is being measured

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

  1. Overall Survival (24-month Rate Reported)

    Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur after at least 281 deaths have been observed, unless an early stopping rule was satisfied.

    Measured: From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months.

Secondary outcomes (5)

  1. Local Failure (24-month Rate Reported)

    Local failure (LF) was defined as residual cancer on posttreatment biopsy findings or biopsy-proven recurrent primary disease and local failure time was measured from randomization to failure or last follow-up. Nonprotocol surgery to the primary site with gross residual disease was considered a LF as of the surgery date. Patients with no viable disease or microscopic residual disease at nonprotocol surgery were censored for LF as of the surgery date. Local failure was estimated by the cumulative incidence method with death considered a competing risk.

    Measured: From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months.

  2. Percentage of Patients With Acute Grade 4 or 5 Non-hematologic Treatment-related Adverse Events

    Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE

    Measured: From start of treatment to 90 days from end of treatment

  3. Endoscopic Complete Response Rate

    All patients were to undergo a repeat endoscopy (EUS) 6-8 weeks after the completion of chemoradiation. At the time of EUS a visual inspection of the site of the original primary disease would be documented. Those patients found to be free of disease were NOT required to undergo repeat biopsy. These patients would be scored as clinical complete responses (cCR). Patients deemed to have residual disease or suspicion of residual disease would undergo a biopsy in order to pathologically confirm findings. Any patient with pathologically confirmed residual disease would be scored as a local failure. Patients who were pathologically proven to have no evidence of disease would be scored as cCRs.

    Measured: From randomization to 6-8 weeks after completion of chemoradiation (11-14 weeks)

  4. Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment

    The ECS is a 17-item self-report instrument designed to measure multidimensional quality of life in patients with esophagus cancer. It is to be administered with the Functional Assessment of Cancer Therapy - General (FACT-G). There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score which ranges from 0-68. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-E including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicated better QOL. Improvement in FACT-E score is defined as an increase from baseline score of at least 5 points.

    Measured: Baseline, 6-8 weeks after completion of chemoradiation , 1 year and 2 years from treatment start.

  5. Quality-adjusted Survival (Using EQ-5D), Only if Primary Hypothesis is Supported

    Measured: Baseline, 6-8 weeks after completion of chemoradiation, 1 year and 2 years from treatment start.

Timeline

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

  1. First posted10 Apr 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionApr 2015
  4. Study completion20 May 2022

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00655876
Sponsor's protocol ID
RTOG 0436
Other IDs
CDR0000538085
Status last verified
May 2022
First submitted
9 Apr 2008
Last updated
14 Jun 2022
Data monitoring committee
Yes

Publications

  • Suntharalingam M, Winter K, Ilson D, Dicker AP, Kachnic L, Konski A, Chakravarthy AB, Anker CJ, Thakrar H, Horiba N, Dubey A, Greenberger JS, Raben A, Giguere J, Roof K, Videtic G, Pollock J, Safran H, Crane CH. Effect of the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation Therapy for Patients With Esophageal Cancer: The NRG Oncology RTOG 0436 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2017 Nov 1;3(11):1520-1528. doi: 10.1001/jamaoncol.2017.1598.

    PubMed 28687830

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cetuximab, cisplatin and paclitaxel in people with Esophageal Cancer, run by Radiation Therapy Oncology Group at 175 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 175 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (24-month Rate Reported) (time frame: From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00655876, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in