Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal TME

National Cancer Center (NCC)

Status: Unknown

Conditions: Rectal Cancer

Treatments: Procedure: Transanal total mesorectal excision

Study type: Interventional

Funder types: Other

Identifiers

NCT02406118

NCC2015-0033

Details and patient eligibility

About

The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.

Full description

Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Enrollment: 49 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age: 20-80 years
2. biopsy-proven adenocarcinoma of the rectum
3. clinical staging (c or yc): T0-3, N0-2, M0
4. Rectal cancer located 3-12 cm from the anal verge
5. ECOG performance status: 2 or less
6. BMI: less than 30

Exclusion criteria

1. Synchronous colon cancer or other malignancy
2. Obstructing rectal cancer
3. Pregnant or breast-feeding
4. Receiving any other study agents
5. Fecal incontinence
6. History of prior colorectal cancer or inflammatory bowel disease
7. Tumor size: more than 7cm in long diameter
8. CRM: mesorectal fascia involvement or less than 1 mm on MRI

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Transanal total mesorectal excision

Experimental group

Description:

Laparoscopy-assisted transanal total mesorectal excision

Treatment:

Procedure: Transanal total mesorectal excision