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Clinical Trial 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


Clinical Trial 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. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01129700
Study type Interventional
Source National Cancer Center, Korea
Contact
Status Completed
Phase Phase 2
Start date February 2010
Completion date February 2012

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