NCT01129700

Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer

Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Multi-institutional Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Concurrent chemoradiotherapy (CRT) * Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1) * ↓ ↓ ↓ ↓ ↓ * Radical surgery 6 weeks after completion of chemoradiotherapy * ↑ ↑ ↑ ↑ ↑ D1 - - - - - D5 * 5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy

Detailed description

Radiotherapy using tomotherapy is delivered in 5 Gy daily fractions for a total of 25 Gy in 5 fractions. A bolus injection of 5-fluorouracil (400 mg/m2/d)and leucovorin (20 mg/m2/d) is delivered concurrently on day 1-5 during radiotherapy. Total mesorectal excision is performed within 6±2 weeks. The pathological response of downstaing is the study endpoint.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Radiation: short-course preoperative chemoradiotherapy	Drug: 5-Fluorouracil 5-Fluorouracil is administered intravenously at a dose of 400 mg/m2 once daily continuous regimen during RT(5 days). Radiation: Localization, simulation and immobilization Radiation dose and planning Total dose 25Gy, 5 fractions (5 Gy/day).

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-05-25
• Last updated: 2012-04-27

Locations

1 site across 1 country: South Korea