- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03400657
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
Conditions
Intervention / Treatment
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:
- Histopathological diagnosis of recurrent / metastatic gastric or colorectal cancer.
- Participate in formal MDT discussions at the Research Center.
- MDT decision-making at least two subjects involved in treatment.
- Patient informed consent and signed written consent.
Exclusion Criteria:
- Early or locally advanced gastric cancer or colorectal cancer.
- Accept informal MDT discussions.
- MDT decisions recommend only a single subject for treatment of patients.
- 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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSMDT-01
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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