Spots Global Cancer Trial Database for Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer
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Trial Identification
Brief Title: Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer
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
Study ID: NCT00655876
Conditions
Study Description
Brief 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. 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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
Baptist-South Miami Regional Cancer Program, Miami, 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, Saint Louis, Missouri, United States
Missouri Baptist Cancer Center, Saint Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy, Saint 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, 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 Village, 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
Dixie Regional Medical Center - East Campus, Saint George, 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
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
Contact Details
Name: Mohan Suntharalingam, MD
Affiliation: University of Maryland Greenebaum Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: David H. Ilson, MD, PhD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR
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