Treatment Strategy for Rectal Cancer Patients With Complete Clinical Response

NCT03846726 | Completed

• 1 other identifier: B2018-174-01
• Study Type: observational
• Target: 513
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer; Organ Preservation

Keywords

Rectal Cancer; clinical complete response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

observation group

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

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

Procedure: standard TME surgery

Interventions

standard TME surgery PROCEDURE

radical resection for rectal cancer

surgery group

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response were included and divided into two groups according to the treatment followed.

You may qualify if:

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

You may not qualify if:

• history of a second primary malignancy.

Sponsors & Collaborators

• Yuan-hong Gao: lead
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Fujian Medical University Union Hospital: collaborator
• Fujian Cancer Hospital: collaborator
• Tongji Hospital: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yuan-hong Gao, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 20, 2019
• Study Start: January 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

CN (1)