Treatment Strategy for Rectal Cancer Patients With Complete Clinical Response

Completed

• Conditions: Organ Preservation; Rectal Cancer
• Interventions: Procedure: standard TME surgery

• Registration Number: NCT03846726
• Lead Sponsor: Yuan-hong Gao

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-20
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 513

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
surgery group	standard TME surgery	Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response, and received radical resection.

Primary Outcome Measures

Name	Time	Method
PFS	the time from the date of treatment started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months	progression-free survival

Secondary Outcome Measures

Name	Time	Method
OS	Overall survival was calculated from the date of first treatment until death from any cause or was censored at last follow-up, assessed up to 60 months	overall survival

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China