Conditions: Rectal Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 60
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the pathological complete tumor response rate.

Detailed description:

Arms:
arm 1: Eligible participants received capecitabine 1000 milligrams per square meter (mg/m\^2) on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.

Interventions: intervention 1: Capecitabine intervention 2: Oxaliplatin
Intervention descriptions: intervention 1: Capecitabine is available as 50 mg and 500 mg tablets. It will be administered as a 1000mg/m\^2 bid orally on Days 1-14, and at a dose of 825mg/m\^2 bid on Days 22-35 and 43-56. intervention 2: Oxaliplatin is available in vials containing 50 mg or 100 mg. It will be administered as a oxaliplatin 130mg/m\^2/d intravenously on Day 1 and 50mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy up to Week 9 followed by surgery period.

Protocol document: