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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00655876
First received: April 9, 2008
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Biological: cetuximab
Drug: cisplatin
Drug: paclitaxel
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall survival (failure: death due to any cause) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local control (failure: residual cancer on post-treatment endoscopic biopsy or recurrent primary disease as defined in protocol) [ Designated as safety issue: No ]
  • Adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Endoscopic complete response rate [ Designated as safety issue: No ]
  • Health-related quality of life (FACT-E) [ Designated as safety issue: No ]
  • Quality-adjusted survival (using EQ-5D), if primary hypothesis is supported [ Designated as safety issue: No ]
  • Tissue handling/storage for future studies [ Designated as safety issue: No ]

Estimated Enrollment: 420
Study Start Date: June 2008
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive cetuximab IV over 1-2 hours, paclitaxel IV over 1 hour, and cisplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Patients also undergo radiotherapy once daily, 5 days a week, for 5½ weeks.
Biological: cetuximab
Given IV
Drug: cisplatin
Given IV
Drug: paclitaxel
Given IV
Radiation: radiation therapy
Given 5 days a week for 5½ weeks
Active Comparator: Arm II
Patients receive paclitaxel and cisplatin as in arm I. Patients also undergo radiotherapy as in arm I.
Drug: cisplatin
Given IV
Drug: paclitaxel
Given IV
Radiation: radiation therapy
Given 5 days a week for 5½ weeks

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 score of the 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.

NOTE: * The adenocarcinoma stratum is closed as of 5/3/2012.

  • Arm I: Patients receive cetuximab IV over 1-2 hours, paclitaxel IV over 1 hour, and cisplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Patients also undergo radiotherapy once daily, 5 days a week, for 5½ weeks for a total dose of 50.4Gy.
  • Arm II: Patients receive paclitaxel and cisplatin as in arm I. Patients also undergo radiotherapy as in arm I.

Patients undergo endoscopy 6 to 8 weeks after completion of chemoradiotherapy. Quality of life is assessed at baseline, within 1 week of post-treatment endoscopy, and at 1 and 2 years from beginning of study treatment.

After completion of study treatment, patients are followed periodically.

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary squamous cell or adenocarcinoma* of the esophagus or gastroesophageal junction

    • 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
    • Patients with cervical esophageal carcinoma are eligible
    • Patients with celiac, perigastric, mediastinal, or supraclavicular adenopathy are eligible NOTE: * The adenocarcinoma stratum is closed as of 5/3/2012.
  • Stage T1, N1, M0; T2-4, Any N, M0; or Any T, Any N, M1a disease based on history/physical examination, endoscopy with biopsy, AND PET/PET-CT scan or chest/abdominal CT scan within 6 weeks prior to registration
  • Disease must be encompassed in a radiotherapy field
  • No evidence of tracheoesophageal fistulas 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

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelets ≥ 100,000 cells/mm³
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL allowed)
  • Creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT ≤ 3 times ULN
  • Negative pregnancy test
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Total intake (oral/enteral) must be ≥ 1,500 kCal/day
  • No prior invasive malignancy except nonmelanomatous skin cancer (e.g., carcinoma in situ of the breast, oral cavity, or cervix) unless disease-free for ≥ 2 years
  • No prior allergic reaction to the study drugs
  • No prior severe infusion reaction to a monoclonal antibody
  • No severe, active comorbidity, including any of the following:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 3 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
    • Acquired immune deficiency syndrome based upon current CDC definition

      • HIV testing is not required for entry into this study

PRIOR CONCURRENT THERAPY:

  • No prior systemic chemotherapy for esophageal cancer (prior chemotherapy for another cancer allowed)
  • No prior therapy that specifically and directly targets the EGFR pathway
  • No prior platinum-based and/or paclitaxel-based therapy
  • No prior radiotherapy that would result in overlap of planned study radiotherapy fields
  • No concurrent investigational agent
  • No concurrent cytotoxic agent
  • No other concurrent radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655876

  Hide Study Locations
Locations
United States, Arizona
Arizona Oncology - Tucson
Tucson, Arizona, United States, 85704
United States, California
Auburn Radiation Oncology
Auburn, California, United States, 95603
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States, 95682
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States, 95608
Enloe Cancer Center at Enloe Medical Center
Chico, California, United States, 95926
California Cancer Center - Woodward Park Office
Fresno, California, United States, 93720
Saint Agnes Cancer Center at Saint Agnes Medical Center
Fresno, California, United States, 93720
Memorial Medical Center
Modesto, California, United States, 95355
Radiation Oncology Center - Roseville
Roseville, California, United States, 95661
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Mercy General Hospital
Sacramento, California, United States, 95819
Solano Radiation Oncology Center
Vacaville, California, United States, 95687
Sutter Solano Medical Center
Vallejo, California, United States, 94589
United States, Colorado
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States, 80012
Porter Adventist Hospital
Denver, Colorado, United States, 80210
United States, Connecticut
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
William W. Backus Hospital
Norwich, Connecticut, United States, 06360
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States, 33458
Center for Cancer Care and Research at Watson Clinic, LLP
Lakeland, Florida, United States, 33805
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806
United States, Georgia
John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Hawaii Medical Center - East
Honolulu, Hawaii, United States, 96817
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States, 96813
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702
United States, Indiana
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, United States, 46016
Bloomington Hospital Regional Cancer Institute
Bloomington, Indiana, United States, 47403
Radiation Oncology Associates Southwest
Fort Wayne, Indiana, United States, 46804
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States, 46805
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46202
Central Indiana Cancer Centers - East
Indianapolis, Indiana, United States, 46219
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
United States, Kentucky
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, United States, 21204
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States, 02721
United States, Michigan
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
United States, Minnesota
MeritCare Bemidji
Bemidji, Minnesota, United States, 56601
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Minnesota Oncology - Maplewood
Maplewood, Minnesota, United States, 55109
United Hospital
Saint Paul, Minnesota, United States, 55102
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216
United States, Missouri
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, United States, 63703
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
United States, Montana
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
United States, Nebraska
Lakeside Hospital
Omaha, Nebraska, United States, 68130
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Payson Center for Cancer Care at Concord Hospital
Concord, New Hampshire, United States, 03301
Seacoast Cancer Center at Wentworth - Douglass Hospital
Dover, New Hampshire, United States, 03820
Center for Cancer Care at Exeter Hospital
Exeter, New Hampshire, United States, 03833
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States, 03431
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta, New Jersey, United States, 07871
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States, 08755
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
New York Oncology Hematology, PC at Albany Regional Cancer Care
Albany, New York, United States, 12206
Lourdes Regional Cancer Center
Binghamton, New York, United States, 13905
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States, 12801
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
New York, New York, United States, 10025
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Beth Israel Medical Center - Petrie Division
New York, New York, United States, 10003-3803
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States, 10591
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina, United States, 27216
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Barberton Citizens Hospital
Barberton, Ohio, United States, 44203
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States, 44710-1799
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, United States, 44708
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Southwest General Health Center
Middleburg Heights, Ohio, United States, 44130
UHHS Chagrin Highlands Medical Center
Orange Village, Ohio, United States, 44122
Robinson Radiation Oncology
Ravenna, Ohio, United States, 44266
UHHS Westlake Medical Center
Westlake, Ohio, United States, 44145
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Willamette Valley Cancer Center - Eugene
Eugene, Oregon, United States, 97401
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
United States, Pennsylvania
UPMC Cancer Center at Beaver Medical Center
Beaver, Pennsylvania, United States, 15009
UPMC Cancer Center at Jefferson Regional Medical Center
Clairton, Pennsylvania, United States, 15025
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Regional Cancer Center - Erie
Erie, Pennsylvania, United States, 16505
Adams Cancer Center
Gettysburg, Pennsylvania, United States, 17325
UPMC Cancer Center - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Frankford Hospital Cancer Center - Torresdale Campus
Philadelphia, Pennsylvania, United States, 19114
UPMC Cancer Center at UPMC Passavant
Pittsburgh, Pennsylvania, United States, 15237
UPMC - Shadyside
Pittsburgh, Pennsylvania, United States, 15213-2582
UPMC Cancer Center at UPMC St. Margaret
Pittsburgh, Pennsylvania, United States, 15215
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States, 16346
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States, 17405
United States, Rhode Island
Northmain Radiation Oncology
Providence, Rhode Island, United States, 02904
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
CCOP - Greenville
Greenville, South Carolina, United States, 29615
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States, 29605
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, United States, 29672
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States, 29307
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
Texas Oncology, PA at Harris Center HEB
Bedford, Texas, United States, 76022
Texas Oncology, PA at Texas Cancer Center - Denton South
Denton, Texas, United States, 76210
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, United States, 76104
Memorial Hermann Hospital - Memorial City
Houston, Texas, United States, 77024
Longview Cancer Center
Longview, Texas, United States, 75601
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
Cancer Care Centers of South Texas - Northeast
San Antonio, Texas, United States, 78217
Texas Oncology, PA at Texas Cancer Center - Sherman
Sherman, Texas, United States, 75090
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States, 77479
Tyler Cancer Center
Tyler, Texas, United States, 75702
Texas Oncology, PA - Wichita Falls
Wichita Falls, Texas, United States, 76310
United States, Utah
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
United States, Washington
Northwest Cancer Specialists at Vancouver Cancer Center
Vancouver, Washington, United States, 98684
United States, West Virginia
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States, 53295
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Door County Cancer Center at Door County Memorial Hospital
Sturgeon Bay, Wisconsin, United States, 54235-1495
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Quebec
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Mohan Suntharalingam, MD University of Maryland Greenebaum Cancer Center
Study Chair: David H. Ilson, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00655876     History of Changes
Other Study ID Numbers: RTOG 0436, CDR0000538085
Study First Received: April 9, 2008
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Radiation Therapy Oncology Group:
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

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cetuximab
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014