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

National Cancer Center (NCC)

Status and phase: Unknown; Phase 2

Conditions: Rectal Cancer

Treatments: Procedure: Local excision

Study type: Interventional

Funder types: Other

Identifiers

NCT02490709

NCC-LE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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86 participants in 1 patient group

Local excision

Experimental group

Description:

Local excision for rectal cancer with good response

Treatment:

Procedure: Local excision