Treatment Strategy for Rectal Cancer Patients With Complete Clinical Response

Yuan-hong Gao

Status: Completed

Conditions: Organ Preservation; Rectal Cancer

Treatments: Procedure: standard TME surgery

Study type: Observational

Funder types: Other

Identifiers

NCT03846726

B2018-174-01

Details and patient eligibility

About

This was a propensity-score matched observational analysis, comparing the oncological outcome of surgical resection vs watch and wait apporach for rectal cancer patients with a cCR.

Full description

Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response from the year 2010 to 2018 were included. Sequential subjects were identified from a prospective maintained database in the Sun Yat-sen University Cancer Center. Clinical experts on rectal cancer from other 5 regional medical centers in China were also invited to participate, and provided data of cCR patients. Standardized forms for data collection were sanded to researchers in each center. Patients received radical resection will constituted our surgery group. Those refused surgery constituted the observation group who went on with the watch and wait approach. A propensity-score matched observational analysis will be used to compare the oncological outcome of these two groups.

Enrollment: 513 patients

Sex: All

Ages: 16 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response

Exclusion criteria

• history of a second primary malignancy.

Trial design

513 participants in 2 patient groups

observation group

Description:

Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response, and refused surgery but went on with the watch and wait approach.

surgery group

Description:

Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response, and received radical resection.

Treatment:

Procedure: standard TME surgery