Skip to main content
OpenTrials
Completed

NCT Number: NCT03846726

Treatment Strategy for Rectal Cancer Patients With Complete Clinical Response

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Organ Preservation Rectal Diseases Rectal Neoplasms

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard TME surgery

Procedure

radical resection for rectal cancer

Primary outcomes

  1. PFS

    Time frame: 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 outcomes

  1. OS

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Yuan-hong Gao

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 20, 2019
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.