NCT03846726

Treatment Strategy for Rectal Cancer Patients With Complete Clinical Response

Watch-and-wait Approach Versus Surgical Resection for Rectal Cancer Patients With Complete Clinical Response After Chemoradiotherapy: a Multi-center Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 513 (actual)
• Sponsor: Yuan-hong Gao · Academic / Other
• Sex: All
• Age: 16 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer
• Organ Preservation

Interventions

Type	Name	Description
PROCEDURE	standard TME surgery	radical resection for rectal cancer

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-02-28
• Completion: 2019-02-28
• First posted: 2019-02-20
• Last updated: 2023-04-14

Locations

1 site across 1 country: China