MDT to Evaluate the Survival Benefit of Patients With Advanced Gastric / Colorectal Cancer

January 9, 2018 updated by: Shen Lin, Peking University

A Prospective, Multicenter, Prospective, Non-intervention, Controlled Trial of MDT to Evaluate the Survival Benefit of Patients With Advanced Gastric / Colorectal Cancer in Realistic Medical Practice

This is a prospective, multicenter, non-interventional, controlled clinical study. Evaluate MDT performance and benefit analysis in patients with advanced gastric or colorectal cancer after MDT discussion under real medical practice.

Study Overview

Status

Unknown

Study Type

Observational

Enrollment (Anticipated)

484

Contacts and Locations

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

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

recurrent / metastatic gastric or colorectal cancer

Description

Inclusion Criteria:

  1. Histopathological diagnosis of recurrent / metastatic gastric or colorectal cancer.
  2. Participate in formal MDT discussions at the Research Center.
  3. MDT decision-making at least two subjects involved in treatment.
  4. Patient informed consent and signed written consent.

Exclusion Criteria:

  1. Early or locally advanced gastric cancer or colorectal cancer.
  2. Accept informal MDT discussions.
  3. MDT decisions recommend only a single subject for treatment of patients.
  4. MDT decisions recommend only palliative patients.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
fully implemented to the MDT decision
group of patients fully implemented to the MDT decision
due to suggestion of Multi-disciplinary Treatment ,the patients would be suggested to chemotherapy or surgery.
not completly implemented to the MDT-decision
group of patients not completly implemented to the MDT decision
due to suggestion of Multi-disciplinary Treatment ,the patients would be suggested to chemotherapy or surgery.
not implemented to the MDT decision
group of patients not implemented to the MDT decision
due to suggestion of Multi-disciplinary Treatment ,the patients would be suggested to chemotherapy or surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in overall survival after performing MDT at center
Time Frame: 1 years
Differences in overall survival after performing MDT at center
1 years

Collaborators and Investigators

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

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)

November 1, 2017

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 9, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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