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Brief Title: Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer
Official Title: Two-Week COurse Versus Conventionally Fractionated Preoperative Chemoradiotherapy In Locally Advanced Rectal Cancer (TwoArc Trial): A Phase III Randomized Clinical Trial
Study ID: NCT02484040
Brief Summary: The investigators compare two-week course of chemoradiation (33 Gy in 10 fractions with oral capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and leucovorin) in this randomized trial.
Detailed Description: 1.1 experimental arm Two-week course concurrent chemoradiotherapy * Radiotherapy, 33 Gy/10 fractions for 2 weeks ↓↓↓↓↓ ↓↓↓↓↓ Radical surgery 6 weeks after completion of chemoradiotherapy D1----------------------D12 * Capecitabine 825 mg/m2, twice daily 1.2 control arm Standard concurrent chemoradiotherapy (CRT) * Radiotherapy, 50.4 Gy/28 fractions for 6 weeks ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓ Radical surgery D1--------------------------------------------------------------------------D38 * Bolus 5-FU, 400 mg/ m2 and leucovorin, 20 mg/ m2 during week 1 and 5 * Capecitabine, 825 mg/ m2, bid
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Lee Jong Hoon, Suwon, , Korea, Republic of
Name: Jong Hoon Lee, MD
Affiliation: St. Vincent's Hospital, The Catholic University of Kora
Role: PRINCIPAL_INVESTIGATOR