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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2020-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison Between Tailored Surgery Versus Total Mesorectal Excision in ycT2-3N0M0

NCT05164315

Rectal Cancer, Adenocarcinoma

TERMINATED NA

Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low/Ultra-Low Rectal Cancer

NCT06949098

Rectal Cancer Stage I

RECRUITING PHASE2

Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis

NCT03022734

Rectal Cancer, Metastatic

UNKNOWN PHASE2

Radical vs Local Excision for Rectal Cancer With Clinically Complete Remission

NCT05964530

Rectal Cancer

RECRUITING NA

The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer

NCT05984485

Rectal Cancer

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Local excision

Local excision for rectal cancer with good response

Group Type EXPERIMENTAL

Local excision

Intervention Type PROCEDURE

Local excision for rectal cancer with good response

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Local excision

Local excision for rectal cancer with good response

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No