9
Participants
Start Date
June 12, 2014
Primary Completion Date
September 30, 2021
Study Completion Date
January 31, 2023
Endo-HDR (if randomized to this arm)
Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
capecitabine and IMRT (if randomized to this arm)
Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy
IMRT (intensity modulated radiation therapy)
Patients will receive IMRT along with capecitabine. External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications
FOLFOX6
"* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion~* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions~* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus An outpatient, 46 hour continuous IV infusion provided by a home IV infusion company. The 5FU is delivered by a small pump worn in a fanny pack around the waist. The home IV infusion company will arrange your disconnect at the end of the infusion."
Surgery
"After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine:~Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.~Mobility of tumor as assessed if possible by rectal exam Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis."
Beth Israel Hospital, New York
The SKCCC at Johns Hopkins, Baltimore
Winship Cancer Institute, Emory University, Atlanta
Moffitt Cancer Center, Tampa
Elekta Limited
INDUSTRY
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER