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

July 2, 2015 updated by: Jae Hwan Oh, National Cancer Center, Korea

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • Recruiting
        • National Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Local excision
Local excision for rectal cancer with good response
Procedure: Local excision
Local excision for rectal cancer with good response

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year disease free survival
Time Frame: 1-5 years
Death or recurrence as an event
1-5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate
Time Frame: 1-5 years
The rate of complete response of the tumor after neoadjuvant chemoradiotherapy
1-5 years
Overall survival rate
Time Frame: 1-5 years
Death as an event
1-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Oh Jae Hwan, MD, PhD, National Cancer Center, Republic of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 7, 2015

Study Record Updates

Last Update Posted (Estimate)

July 7, 2015

Last Update Submitted That Met QC Criteria

July 2, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC-LE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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