Local Excision of Clinical T3 Rectal Adenocarcinoma Showing Major Response(ycT0-1) After Neoadjuvant Chemoradiotherapy

Phase 2

• Conditions: Rectal Cancer
• Interventions: Procedure: Local excision

• Registration Number: NCT02490709
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

The purpose of this study is evaluation of the safety and the efficacy of transanal local excision in patients with cT3 rectal cancer which was downstaged into ycT0-1 after neoadjuvant chemoradiotherapy.

Detailed Description

This study is a prospective multicenter single-arm phase II clinical trial. Rectal cancer patients with cT3 stage will receive neoadjuvant chemoradiotherapy, and be evaluated the response of the tumor in 6 to 10 weeks after completion of neoadjuvant chemoradiotherapy. For those who have good response (ycT0-1) will underwent transanal local excision under the patients' agree.

Study Timeline

• Study Start: 2015-04
• Status Verified: 2015-07
• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-02
• Last Update Submitted: 2015-07-02
• Study First Posted: 2015-07-07
• Last Update Posted: 2015-07-07
• Primary Completion: 2020-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• age: more than 20 years
• biopsy-proven adenocarcinoma of the rectum
• clinical staging, cT3NxM0
• Rectal cancer located 8 cm from the anal verge
• Restaging in 6-10 weeks after completion of neoadjuvant chemoradiotherapy, ycT0-1N0M0
• ECOG performance status 2 or less

Exclusion Criteria

• Synchronous colon cancer or other malignancy
• Obstructing rectal cancer
• Pregnant or breast-feeding
• Receiving any other study agents
• History of prior colorectal cancer or inflammatory bowel disease
• Hereditary colorectal cancer (FAP, HNPCC)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Local excision	Local excision	Local excision for rectal cancer with good response

Primary Outcome Measures

Name	Time	Method
3-year disease free survival	1-5 years	Death or recurrence as an event

Secondary Outcome Measures

Name	Time	Method
Complete response rate	1-5 years	The rate of complete response of the tumor after neoadjuvant chemoradiotherapy
Overall survival rate	1-5 years	Death as an event

Trial Locations

Locations (1)

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