Treatment Strategy for Rectal Cancer Patients With Complete Clinical Response

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03846726
• Other study ID #: B2018-174-01
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 513
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Organ Preservation
• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• standard TME surgery
radical resection for rectal cancer

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (7)

Lead Sponsor	Collaborator
Yuan-hong Gao	Fujian Cancer Hospital, Fujian Medical University Union Hospital, Peking University Cancer Hospital & Institute, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sixth Affiliated Hospital, Sun Yat-sen University, Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	progression-free survival	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
Secondary	OS	overall survival	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