Choice of the Optimal Treatment Strategies for Mid-low REctal Cancer (COMREC)

August 24, 2023 updated by: Peking Union Medical College Hospital

Choice of the Optimal Treatment Strategies for Mid-low REctal Cancer-a National Multi-center, Prospective, Real World Study

The purpose of this study is to compare the efficacy, prognosis, health economics of different treatment modalities of mid-low rectal cancer in different centers in China, and to conduct cost utility analysis (CUA) on the treatment process of rectal cancer to explore the best treatment modality that meets the actual need of medical units in each region and at each level. The investigators hope to provide evidence-based medical suggestions for medical quality control of rectal cancer and revision of clinical guidelines, and provides a source of decision making for medical management and medical insurance.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3705

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yi Xiao, Professor
  • Phone Number: +86 13366036387
  • Email: Xiaoy@pumch.cn

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

mid-low rectal cancer patients

Description

Inclusion Criteria:

  • pathologically confirmed rectal adenocarcinoma
  • located within 12cm below the anal verge

Exclusion Criteria:

  • diagnosed with distant metastasis
  • multiple primary colorectal cancers
  • history of previous malignant tumors
  • Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year OS
Time Frame: 3 years
3-year overall survival
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year DFS
Time Frame: 3 years
3-year disease-free survival
3 years
3-year LR
Time Frame: 3 years
3-year local recurrence rate
3 years
3-year distant metastasis rate
Time Frame: 3 years
3-year distant metastasis rate
3 years
neoadjuvant therapy rate
Time Frame: at the time point of surgery of the primary lesion
the percentage of patients who underwent standard neoadjuvant therapy
at the time point of surgery of the primary lesion
adjuvant therapy rate
Time Frame: at the time point of 3-year follow up
the percentage of patients who underwent standard adjuvant therapy
at the time point of 3-year follow up
EUS/MRI assessment rate
Time Frame: at the time point of surgery of the primary lesion
the percentage of patients who underwent standard rectal EUS/MRI assessment
at the time point of surgery of the primary lesion
R0 resection rate
Time Frame: at the time point of surgery of the primary lesion
the percentage of patients who underwent R0 resection
at the time point of surgery of the primary lesion
CCR
Time Frame: immediately after the completion of neoadjuvant therapy assessment
Clinical Complete Response
immediately after the completion of neoadjuvant therapy assessment
pCR
Time Frame: immediately after the completion of surgery
Pathologic Complete Response
immediately after the completion of surgery
30-day mortality
Time Frame: 30 days after the surgery
death occurring within 30 days of the surgery
30 days after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2023

Primary Completion (Estimated)

May 17, 2027

Study Completion (Estimated)

May 17, 2027

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 21, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-PUMCH-C-027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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