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Clinical Trials/NCT02490709
NCT02490709
Unknown
Phase 2

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

National Cancer Center, Korea1 site in 1 country86 target enrollmentStarted: April 2015Last updated:
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ConditionsRectal Cancer

Overview

Phase
Phase 2
Enrollment
86
Locations
1
Primary Endpoint
3-year disease free survival
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

3-year disease free survival

Time Frame: 1-5 years

Death or recurrence as an event

Secondary Outcomes

  • Complete response rate(1-5 years)
  • Overall survival rate(1-5 years)

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Jae Hwan Oh

Director, Hospital

National Cancer Center, Korea

Study Sites (1)

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