Back to resultsLocal Excision of Clinical T3 Rectal Adenocarcinoma Showing Major Response(ycT0-1) After Neoadjuvant Chemoradiotherapy
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Local excision
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal neoplasms, Colorectal neoplasms, Local excision
Eligibility Criteria
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)
Sites / Locations
- National Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Local excision
Arm Description
Local excision for rectal cancer with good response
Outcomes
Primary Outcome Measures
3-year disease free survival
Death or recurrence as an event
Secondary Outcome Measures
Complete response rate
The rate of complete response of the tumor after neoadjuvant chemoradiotherapy
Overall survival rate
Death as an event
Full Information
NCT ID
NCT02490709
First Posted
July 2, 2015
Last Updated
July 2, 2015
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT02490709
Brief Title
Local Excision of Clinical T3 Rectal Adenocarcinoma Showing Major Response(ycT0-1) After Neoadjuvant Chemoradiotherapy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectal neoplasms, Colorectal neoplasms, Local excision
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Local excision
Arm Type
Experimental
Arm Description
Local excision for rectal cancer with good response
Intervention Type
Procedure
Intervention Name(s)
Local excision
Intervention Description
Local excision for rectal cancer with good response
Primary Outcome Measure Information:
Title
3-year disease free survival
Description
Death or recurrence as an event
Time Frame
1-5 years
Secondary Outcome Measure Information:
Title
Complete response rate
Description
The rate of complete response of the tumor after neoadjuvant chemoradiotherapy
Time Frame
1-5 years
Title
Overall survival rate
Description
Death as an event
Time Frame
1-5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oh Jae Hwan, MD, PhD
Phone
+821071047102
Email
jayoh@ncc.re.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oh Jae Hwan, MD, PhD
Organizational Affiliation
National Cancer Center, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oh Jae Hwan, MD, PhD
Phone
+8271047102
Email
jayoh@ncc.re.kr
12. IPD Sharing Statement
Learn more about this trial
Local Excision of Clinical T3 Rectal Adenocarcinoma Showing Major Response(ycT0-1) After Neoadjuvant Chemoradiotherapy
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