NCT02484040

Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (estimated)
• Sponsor: Jong Hoon Lee · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

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

Conditions

• Response to Toxin
• Toxicity
• Recurrence

Interventions

Type	Name	Description
RADIATION	Two-week course of radiation	33 Gy in 10 fractions for 2 weeks
DRUG	Two-week course of radiation	oral capecitabine, 825mg/m2, bid

Timeline

• Start date: 2015-12-01
• Primary completion: 2019-07-01
• Completion: 2021-07-01
• First posted: 2015-06-29
• Last updated: 2017-06-05

Locations

1 site across 1 country: South Korea