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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02490709
• Other study ID #: NCC-LE
• Status: Recruiting
• Phase: Phase 2
• First received: July 2, 2015
• Last updated: July 2, 2015
• Start date: April 2015
• Est. completion date: April 2020

Study information

• Verified date: July 2015
• Source: National Cancer Center, Korea
• Contact: Oh Jae Hwan, MD, PhD
• Phone: +821071047102
• Email: jayoh[@]ncc.re.kr
• Is FDA regulated: No
• Health authority: Korea: National Cancer Center
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Local excision
Local excision for rectal cancer with good response

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival	Death or recurrence as an event	1-5 years	No
Secondary	Complete response rate	The rate of complete response of the tumor after neoadjuvant chemoradiotherapy	1-5 years	No
Secondary	Overall survival rate	Death as an event	1-5 years	No