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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03846726
Other study ID # B2018-174-01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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