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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02490709

Enrollment

Registered

2015-07-07

Start date

2015-04-30

Completion date

2020-04-30

Last updated

2015-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

Rectal neoplasms, Colorectal neoplasms, Local excision

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.

Interventions

PROCEDURELocal excision

Local excision for rectal cancer with good response

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Contacts

Primary ContactOh Jae Hwan, MD, PhD

jayoh@ncc.re.kr+821071047102

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026