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

Phase 2

Completed

• Conditions: Rectal Cancer

• Registration Number: NCT01129700
• Lead Sponsor: National Cancer Center, Korea

Brief 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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-05-24
• Study First Posted: 2010-05-25
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-25
• Last Update Posted: 2012-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the pathologic response	After surgery with pathology data	downstaging(ypT0-2N0M0)rate

Secondary Outcome Measures

Name	Time	Method
Tumor regression grade & MR volumetry	After surgery with pathology data for TRG, at the pretreatment work-up and 1-4 days befor surgery	To evaluate the tumor regression grade \& MR volumetry
Acute/ late toxicities	preoperative CCRT to 3 months after surgery	To evaluate the acute and late toxicities

Trial Locations

Locations (1)

National Cancer Center Korea; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of