NCT02490709

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

Local Excision of Clinical T3 Mid- or Low-Rectal Adenocarcinoma Showing Major Response(ycT0-1) After Neoadjuvant Chemoradiotherapy: Prospective Multicenter Single-arm Phase II Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Local excision	Local excision for rectal cancer with good response

Timeline

• Start date: 2015-04-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2015-07-07
• Last updated: 2015-07-07

Locations

1 site across 1 country: South Korea