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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02484040
Study type Interventional
Source Seoul St. Mary's Hospital
Contact Jong Hoon Lee, MD
Phone +82-031-249-8440
Email koppul@catholic.ac.kr
Status Recruiting
Phase Phase 3
Start date December 2015
Completion date July 2021

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