Concurrent Chemo-Radiotherapy vs Radiotherapy With Boost in Locally Advanced Unresectable Rectal Cancers. A Randomized Phase II Study
1. To compare the resectability rate when patients are treated when conventional
chemoradiation to patients treated with radiation alone with an additional boost to the
primary tumor in case of unresectable rectal cancers.
2. To study the treatment toxicity and local control rate.
Study methodology This is a phase II Randomised controlled study. Ninety cases of advanced
rectal cancer (Stage II - Stage III) will be divided in two equal groups (Arm I & II)
Arm-1(standard arm) - Patients will receive standard external radiation therapy to pelvis +
concurrent chemotherapy with Tab Capecitabine. This will be followed by surgery at 6-8 weeks
if deemed resectable.
Arm-2 (research arm) Patients in this group will not receive any neo-adjuvant chemotherapy,
instead they will receive radiotherapy alone additional dose of localized radiotherapy
boost. This will be followed by surgery at 6-8 weeks if deemed resectable.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparison of resectability rate of in the two groups at 6-8 weeks following radiotherapy.
Reena Engineer, MD
Tata Memorial Hospital
India: Institutional Review Board