- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02490709
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
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 Contact
- Name: Oh Jae Hwan, MD, PhD
- Phone Number: +821071047102
- Email: jayoh@ncc.re.kr
Study Locations
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
- Recruiting
- National Cancer Center
-
Contact:
- Oh Jae Hwan, MD, PhD
- Phone Number: +8271047102
- Email: jayoh@ncc.re.kr
-
-
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
|
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
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
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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