Recurrence Clinical Trial
Official title:
Two-Week COurse Versus Conventionally Fractionated Preoperative Chemoradiotherapy In Locally Advanced Rectal Cancer (TwoArc Trial): A Phase III Randomized Clinical Trial
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.
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
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