Phase II Study of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin and Bevacizumab Followed by Surgery and Postoperative 5-FU, Leucovorin, Oxaliplatin (FOLFOX) and Bevacizumab in Patients With Locally Advanced Rectal Cancer
PRIMARY OBJECTIVES:
I. Evaluate the pathological complete response rate in patients with T3 or T4 rectal cancer
treated with neoadjuvant bevacizumab in combination with radiotherapy, capecitabine, and
oxaliplatin followed by surgical resection and adjuvant bevacizumab in combination with
fluorouracil, leucovorin calcium, and oxaliplatin.
SECONDARY OBJECTIVES:
I. Evaluate the resection rate for T3 and T4 rectal cancers. II. Evaluate the expected
versus actual type of resection (abdominoperineal resection [APR] vs low anterior resection
[LAR] vs LAR/coloanal anastomosis) performed on these patients.
III. Determine, preliminarily, survival and patterns of recurrence in patients treated with
this regimen.
IV. Determine the toxicity and tolerability of this preoperative and postoperative regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to primary tumor
size (T3 vs T4).
PREOPERATIVE CHEMORADIOTHERAPY: Patients undergo radiotherapy once daily 5 days a week and
receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive
oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90
minutes on days 1, 15, and 29 during radiotherapy.
SURGERY: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo
surgical resection. Patients whose tumors are not completely resected or who have metastatic
disease discontinue protocol therapy.
POSTOPERATIVE CHEMOTHERAPY: Approximately 4-8 weeks after surgery, patients receive
oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over
30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46
hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses in the absence of
disease progression or unacceptable toxicity. Patients then receive up to 3 additional
courses of leucovorin calcium, 5-FU, and bevacizumab.
After completion of study treatment, patients are followed periodically for 10 years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathological complete response rate
A two-stage design will be used and 90% confidence intervals will be provided.
Up to 10 years
No
Jerome Landry
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2009-01081
NCT00321685
July 2006
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Virginia Piper Cancer Institute | Minneapolis, Minnesota 55407 |
Mercy Fitzgerald Hospital | Darby, Pennsylvania 19023 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Medical X-Ray Center | Sioux Falls, South Dakota 57105 |
Swedish Covenant Hospital | Chicago, Illinois 60625 |
Mercy Hospital and Medical Center | Chicago, Illinois 60616 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Hematology Oncology Associates of Illinois-Highland Park | Highland Park, Illinois 60035 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Saint Francis Regional Medical Center | Shakopee, Minnesota 55379 |
Saint Joseph Hospital | Chicago, Illinois 60657 |
Woodwinds Health Campus | Woodbury, Minnesota 55125 |
Northwestern University | Chicago, Illinois 60611 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Emory University | Atlanta, Georgia 30322 |
Albert Einstein Medical Center | Philadelphia, Pennsylvania 19141 |
University of Texas Southwestern Medical Center | Dallas, Texas |
Alegent Health Immanuel Medical Center | Omaha, Nebraska 68122 |
Alegent Health Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
Veterans Administration Medical Center | Decatur, Georgia 30033 |
Rush - Copley Medical Center | Aurora, Illinois 60504 |
Saint Anthony Memorial Hospital | Effingham, Illinois 62401 |
Joliet Oncology-Hematology Associates Limited | Joliet, Illinois 60435 |
Midwest Center for Hematology Oncology | Joliet, Illinois 60432 |
North Shore Hematology Oncology | Libertyville, Illinois 60048 |
Vigliotti, Antonio, P.G. M.D. (UIA Investigator) | Moline, Illinois 61265 |
Stoffel, Thomas J MD (UIA Investigator) | Moline, Illinois 61265 |
Garneau, Stewart C MD (UIA Investigator) | Moline, Illinois 61265 |
Sharis, Christine M MD (UIA Investigator) | Moline, Illinois 61265 |
Porubcin, Michael MD (UIA Investigator) | Moline, Illinois 61265 |
Hematology Oncology Associates of Illinois - Skokie | Skokie, Illinois 60076 |
Edward H Kaplan MD and Associates | Skokie, Illinois 60076 |
Carle Clinic-Urbana Main | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Center | Michigan City, Indiana 46360 |
Constantinou, Costas L MD (UIA Investigator) | Bettendorf, Iowa 52722 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Unity Hospital | Fridley, Minnesota 55432 |
Saint John's Hospital - Healtheast | Maplewood, Minnesota 55109 |
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota 55109 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Saint Joseph's Hospital - Healtheast | Saint Paul, Minnesota 55102 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Lincoln Medical Education Foundation Cancer Resource Center | Lincoln, Nebraska 68510 |
Missouri Valley Cancer Consortium CCOP | Omaha, Nebraska 68106 |
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | Mount Holly, New Jersey 08060 |
Sparta Cancer Treatment Center | Sparta, New Jersey 07871 |
Virtua West Jersey Hospital Voorhees | Voorhees, New Jersey 08043 |
Saint Rita's Medical Center | Lima, Ohio 45801 |
Natalie W Bryant Cancer Center | Tulsa, Oklahoma 74136 |
Pocono Medical Center | East Stroudsburg, Pennsylvania 18301 |
Ephrata Cancer Center | Ephrata, Pennsylvania 17522 |
Riddle Hospital | Media, Pennsylvania 19063 |
Hematology and Oncology Associates of North East Pennsylvania | Scranton, Pennsylvania 18508 |
Associates In Hematology Oncology PC-Upland | Upland, Pennsylvania 19013 |
Sanford Cancer Center-Oncology Clinic | Sioux Falls, South Dakota 57104 |
Jesse Brown Veterans Affairs Medical Center | Chicago, Illinois 60612 |
DuPage Medical Group-Ogden | Naperville, Illinois 60563 |
Hematology Oncology Associates-Berwyn | Berwyn, Illinois 60402 |
Hinsdale Hematology Oncology Associates Incorporated | Hinsdale, Illinois 60521 |
Spector, David MD (UIA Investigator) | Moline, Illinois 61265 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Carle Foundation - Carle Cancer Center | Urbana, Illinois 61801 |
Sanford USD Medical Center - Sioux Falls | Sioux Falls, South Dakota 57117-5134 |
Illinois Cancer Specialists-Niles | Niles, Illinois 60714 |
Underwood-Memorial Hospital | Woodbury, New Jersey 08096 |