Timing of Rectal Cancer Response to Chemoradiation
I. To determine the rate of pathologic complete response to chemoradiation (no evidence of
residual tumor in the resected specimen) of Stage II and Stage III rectal cancers that are
staged preoperatively by endorectal ultrasound (ERUS) or magnetic resonance imaging (MRI),
treated according to a standardized chemoradiation and surgery protocol, and evaluated by a
systematic pathologic exam of the surgical specimen.
II. To study the effect of different chemoradiation-to-surgery intervals on the rate of
pathologic complete response, on surgical difficulty, and on postoperative complications.
III. To investigate the feasibility of using sensitive molecular assays to detect tumor
cells in the tumor bed and regional lymph nodes of rectal cancer specimens, with or without
pathologic complete response to preoperative chemoradiation.
Patients are assigned to 1 of 4 treatment groups. All patients undergo chemoradiation
therapy comprising radiation therapy once daily 5 days a week for 5 weeks and fluorouracil
intravenously (IV) continuously over 24 hours 7 days a week for 6 weeks.
GROUP I (closed to enrollment): Patients undergo standard surgical resection after
completion of chemoradiation therapy.
GROUP II (closed to enrollment): Beginning 4 weeks after completion of chemoradiation
therapy, patients receive modified FOLFOX-6 chemotherapy comprising oxaliplatin IV over 2
hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over
46 hours on days 1-2. Treatment repeats every 14 days for 2 courses. After the last week of
post-radiation chemotherapy, patients undergo standard surgical resection.
GROUP III: Beginning 4 weeks after completion of chemoradiation therapy, patients receive
modified FOLFOX-6 chemotherapy as in group II. Treatment repeats every 14 days for 4
courses. After the last week of post-radiation chemotherapy, patients undergo standard
GROUP IV: Beginning 4 weeks after completion of chemoradiation therapy, patients receive
modified FOLFOX-6 chemotherapy as in group II. Treatment repeats every 14 days for 6
courses. After the last week of post- radiation chemotherapy, patients undergo standard
In all groups, treatment continues in the absence of disease progression or unacceptable
fter completion of study treatment, patients are followed up for 5 years.
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of pathologic complete response
Determined at the time of surgery
Julio Garcia-Aguilar, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Washington Cancer Institute at Washington Hospital Center||Washington, District of Columbia 20010|
|Vermont Cancer Center at University of Vermont||Burlington, Vermont 05405-0075|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Knight Cancer Institute at Oregon Health and Science University||Portland, Oregon 97239-3098|
|Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center||Orange, California 92868|
|City of Hope Medical Center||Duarte, California 91010|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida||Tampa, Florida 33612|
|St. Joseph Hospital Regional Cancer Center - Orange||Orange, California 92868-3849|
|Cancer Care Center at John Muir Health - Concord Campus||Concord, California 94524-4110|
|Colon and Rectal Surgery, Incorporated||Omaha, Nebraska 68114|