Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer
NCT ID: NCT00655876
Last Updated: 2022-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
344 participants
INTERVENTIONAL
2008-06-30
2022-05-20
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Chemoradiation + Cetuximab
External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
cetuximab
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.
cisplatin
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.
paclitaxel
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 therapy
1.8 Gy daily for 28 days (over 5-6 weeks) for a total dose of 50.4 Gy.
Chemoradiation
External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
cisplatin
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.
paclitaxel
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 therapy
1.8 Gy daily for 28 days (over 5-6 weeks) for a total dose of 50.4 Gy.
Interventions
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cetuximab
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.
cisplatin
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.
paclitaxel
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 therapy
1.8 Gy daily for 28 days (over 5-6 weeks) for a total dose of 50.4 Gy.
Eligibility Criteria
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Inclusion Criteria
* 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.
2. 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
* 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.)
3. Zubrod performance status 0-2
4. Age ≥ 18 and ≤ 74 (upper limit was set at 74 in an amendment)
5. 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.)
6. 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
7. Patient's total intake (oral/enteral) must be ≥ 1500 kCal/day
8. Patient must provide study-specific informed consent prior to study entry
9. Women of childbearing potential and male participants must practice adequate contraception
Exclusion Criteria
2. 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).
3. Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a different cancer is allowable.
4. Prior radiation therapy that would result in overlap of planned radiation therapy fields.
5. Prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway.
6. Prior platinum-based and/or paclitaxel-based therapy.
7. Prior allergic reaction to the study drugs involved in this protocol.
8. Prior severe infusion reaction to a monoclonal antibody.
9. 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.
10. 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.
11. Women who are nursing.
18 Years
74 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Mohan Suntharalingam, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland Greenebaum Cancer Center
David H. Ilson, MD, PhD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Arizona Oncology - Tucson
Tucson, Arizona, United States
Auburn Radiation Oncology
Auburn, California, United States
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States
Enloe Cancer Center at Enloe Medical Center
Chico, California, United States
California Cancer Center - Woodward Park Office
Fresno, California, United States
Saint Agnes Cancer Center at Saint Agnes Medical Center
Fresno, California, United States
Memorial Medical Center
Modesto, California, United States
Radiation Oncology Center - Roseville
Roseville, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Mercy General Hospital
Sacramento, California, United States
Solano Radiation Oncology Center
Vacaville, California, United States
Sutter Solano Medical Center
Vallejo, California, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States
William W. Backus Hospital
Norwich, Connecticut, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States
Center for Cancer Care and Research at Watson Clinic, LLP
Lakeland, Florida, United States
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States
John B. Amos Cancer Center
Columbus, Georgia, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States
Hawaii Medical Center - East
Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
Swedish-American Regional Cancer Center
Rockford, Illinois, United States
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, United States
Bloomington Hospital Regional Cancer Institute
Bloomington, Indiana, United States
Radiation Oncology Associates Southwest
Fort Wayne, Indiana, United States
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States
Central Indiana Cancer Centers - East
Indianapolis, Indiana, United States
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
McFarland Clinic, PC
Ames, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, United States
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
St. Mary Mercy Hospital
Livonia, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States
MeritCare Bemidji
Bemidji, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States
Minnesota Oncology - Maplewood
Maplewood, Minnesota, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, United States
Saint Louis University Cancer Center
St Louis, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
Billings Clinic - Downtown
Billings, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
Lakeside Hospital
Omaha, Nebraska, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Payson Center for Cancer Care at Concord Hospital
Concord, New Hampshire, United States
Seacoast Cancer Center at Wentworth - Douglass Hospital
Dover, New Hampshire, United States
Center for Cancer Care at Exeter Hospital
Exeter, New Hampshire, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta, New Jersey, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
New York Oncology Hematology, PC at Albany Regional Cancer Care
Albany, New York, United States
Lourdes Regional Cancer Center
Binghamton, New York, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States
Beth Israel Medical Center - Petrie Division
New York, New York, United States
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Kinston Medical Specialists
Kinston, North Carolina, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Barberton Citizens Hospital
Barberton, Ohio, United States
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States
Lake/University Ireland Cancer Center
Mentor, Ohio, United States
Southwest General Health Center
Middleburg Heights, Ohio, United States
UHHS Chagrin Highlands Medical Center
Orange, Ohio, United States
Robinson Radiation Oncology
Ravenna, Ohio, United States
UHHS Westlake Medical Center
Westlake, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Willamette Valley Cancer Center - Eugene
Eugene, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
UPMC Cancer Center at Beaver Medical Center
Beaver, Pennsylvania, United States
UPMC Cancer Center at Jefferson Regional Medical Center
Clairton, Pennsylvania, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Regional Cancer Center - Erie
Erie, Pennsylvania, United States
Adams Cancer Center
Gettysburg, Pennsylvania, United States
UPMC Cancer Center - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States
Frankford Hospital Cancer Center - Torresdale Campus
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
UPMC - Shadyside
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC St. Margaret
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC Passavant
Pittsburgh, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States
Northmain Radiation Oncology
Providence, Rhode Island, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Harrington Cancer Center
Amarillo, Texas, United States
Texas Oncology, PA at Harris Center HEB
Bedford, Texas, United States
Texas Oncology, PA at Texas Cancer Center - Denton South
Denton, Texas, United States
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, United States
Memorial Hermann Hospital - Memorial City
Houston, Texas, United States
Longview Cancer Center
Longview, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Cancer Care Centers of South Texas - Northeast
San Antonio, Texas, United States
Texas Oncology, PA at Texas Cancer Center - Sherman
Sherman, Texas, United States
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Texas Oncology, PA - Wichita Falls
Wichita Falls, Texas, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Dixie Regional Medical Center - East Campus
St. George, Utah, United States
Northwest Cancer Specialists at Vancouver Cancer Center
Vancouver, Washington, United States
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
Door County Cancer Center at Door County Memorial Hospital
Sturgeon Bay, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States
Saint John Regional Hospital
Saint John, New Brunswick, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada
Countries
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References
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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.
Study Documents
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Document Type: Individual Participant Data Set
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View DocumentOther Identifiers
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CDR0000538085
Identifier Type: -
Identifier Source: secondary_id
RTOG 0436
Identifier Type: -
Identifier Source: org_study_id
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