A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Overall survival (failure: death due to any cause)
No
Mohan Suntharalingam, MD
Study Chair
University of Maryland Greenebaum Cancer Center
Unspecified
CDR0000538085
NCT00655876
June 2008
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Porter Adventist Hospital | Denver, Colorado 80210 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Methodist Cancer Center at Methodist Hospital | Indianapolis, Indiana 46202 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
MeritCare Bemidji | Bemidji, Minnesota 56601 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Aultman Cancer Center at Aultman Hospital | Canton, Ohio 44710-1799 |
Mercy Cancer Center at Mercy Medical Center | Canton, Ohio 44708 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Harrington Cancer Center | Amarillo, Texas 79106 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
University of California Davis Cancer Center | Sacramento, California 95817 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Baptist-South Miami Regional Cancer Program | Miami, Florida 33176 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Rhode Island Hospital Comprehensive Cancer Center | Providence, Rhode Island 02903 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Lourdes Regional Cancer Center | Binghamton, New York 13905 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
M.D. Anderson Cancer Center at Orlando | Orlando, Florida 32806 |
Advocate Lutheran General Cancer Care Center | Park Ridge, Illinois 60068-1174 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
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 10027 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Sutter Solano Medical Center | Vallejo, California 94589 |
Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
William W. Backus Hospital | Norwich, Connecticut 06360 |
California Cancer Center - Woodward Park Office | Fresno, California 93720 |
Cancer Center at Ball Memorial Hospital | Muncie, Indiana 47303 |
Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
John B. Amos Cancer Center | Columbus, Georgia 31904 |
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah, Georgia 31405 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Greater Baltimore Medical Center Cancer Center | Baltimore, Maryland 21204 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Frederick R. and Betty M. Smith Cancer Treatment Center | Sparta, New Jersey 07871 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
York Cancer Center at Apple Hill Medical Center | York, Pennsylvania 17405 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
Enloe Cancer Center at Enloe Medical Center | Chico, California 95926 |
Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii 96813 |
Parkview Regional Cancer Center at Parkview Health | Fort Wayne, Indiana 46805 |
Elliot Regional Cancer Center at Elliot Hospital | Manchester, New Hampshire 03103 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Regional Cancer Center at Oconomowoc Memorial Hospital | Oconomowoc, Wisconsin 53066 |
Kinston Medical Specialists | Kinston, North Carolina 28501 |
Cancer Centers of the Carolinas - Faris Road | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Regional Cancer Center - Erie | Erie, Pennsylvania 16505 |
Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau, Wisconsin 54401 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
Tyler Cancer Center | Tyler, Texas 75702 |
Center for Cancer Care and Research at Watson Clinic, LLP | Lakeland, Florida 33805 |
Mercy General Hospital | Sacramento, California 95819 |
Memorial Medical Center | Modesto, California 95355 |
Hawaii Medical Center - East | Honolulu, Hawaii 96817 |
Center for Cancer Care at Exeter Hospital | Exeter, New Hampshire 03833 |
Cancer Institute of Cape Girardeau, LLC | Cape Girardeau, Missouri 63703 |
J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River, New Jersey 08755 |
Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River, Massachusetts 02721 |
Alamance Cancer Center at Alamance Regional Medical Center | Burlington, North Carolina 27216 |
Frankford Hospital Cancer Center - Torresdale Campus | Philadelphia, Pennsylvania 19114 |
Minnesota Oncology - Maplewood | Maplewood, Minnesota 55109 |
UPMC Cancer Center at Beaver Medical Center | Beaver, Pennsylvania 15009 |
UPMC Cancer Center at Jefferson Regional Medical Center | Clairton, Pennsylvania 15025 |
UPMC Cancer Center - Arnold Palmer Pavilion | Greensburg, Pennsylvania 15601 |
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 |
UPMC Cancer Center at UPMC Northwest | Seneca, Pennsylvania 16346 |
New York Oncology Hematology, PC at Albany Regional Cancer Care | Albany, New York 12208 |
Auburn Radiation Oncology | Auburn, California 95603 |
Radiation Oncology Centers - Cameron Park | Cameron Park, California 95682 |
Radiation Oncology Center - Roseville | Roseville, California 95661 |
Saint John's Cancer Center at Saint John's Medical Center | Anderson, Indiana 46016 |
Northwest Cancer Specialists at Vancouver Cancer Center | Vancouver, Washington 98684 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
St. Agnes Hospital Cancer Center | Baltimore, Maryland 21229 |
Southwest General Health Center | Middleburgh Heights, Ohio 44130 |
UHHS Chagrin Highlands Medical Center | Orange Villager, Ohio 44122 |
UHHS Westlake Medical Center | Westlaker, Ohio 44145 |
Longview Cancer Center | Longview, Texas 75601 |
Lakeside Hospital | Omaha, Nebraska 68130 |
Clackamas Radiation Oncology Center | Clackamas, Oregon 97015 |
Radiation Oncology Associates Southwest | Fort Wayne, Indiana 46804 |
Central Indiana Cancer Centers - East | Indianapolis, Indiana 46219 |
Payson Center for Cancer Care at Concord Hospital | Concord, New Hampshire 03301 |
Seacoast Cancer Center at Wentworth - Douglass Hospital | Dover, New Hampshire 03820 |
Willamette Valley Cancer Center - Eugene | Eugene, Oregon 97401 |
Northmain Radiation Oncology | Providence, Rhode Island 02904 |
Texas Oncology, PA at Harris Center HEB | Bedford, Texas 76022 |
Texas Oncology, PA at Texas Cancer Center - Denton South | Denton, Texas 76210 |
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital | Fort Worth, Texas 76104 |
Cancer Care Centers of South Texas - Northeast | San Antonio, Texas 78217 |
Texas Oncology, PA at Texas Cancer Center - Sherman | Sherman, Texas 75090 |
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land | Sugar Land, Texas 77479 |
Bloomington Hospital Regional Cancer Institute | Bloomington, Indiana 47403 |
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Sleepy Hollow, New York 10591 |
Arizona Oncology - Tucson | Tucson, Arizona 85704 |
Rocky Mountain Cancer Centers - Aurora | Aurora, Colorado 80012 |
Door County Cancer Center at Door County Memorial Hospital | Sturgeon Bay, Wisconsin 54235-1495 |
Adams Cancer Center | Gettysburg, Pennsylvania 17325 |
Robinson Radiation Oncology | Ravenna, Ohio 44266 |
Saint Agnes Cancer Center at Saint Agnes Medical Center | Fresno, California 93720 |
Memorial Hermann Hospital - Memorial City | Houston, Texas 77024 |
Texas Oncology, PA - Wichita Falls | Wichita Falls, Texas 76310 |