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Spots Global Cancer Trial Database for Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer

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Trial Identification

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

Study Description

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

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Lee Jong Hoon, Suwon, , Korea, Republic of

Contact Details

Name: Jong Hoon Lee, MD

Affiliation: St. Vincent's Hospital, The Catholic University of Kora

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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