- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02923622
Efficacy and Safety Evaluation of Traditional Chinese Medicine in the Treatment of Advanced Colorectal Cancer
October 1, 2016 updated by: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Although patients of colorectal cancer use Traditional Chinese Medicine (TCM) herbal therapy extensively in China, no strong evidence exists to demonstrate the safety and survival outcomes of TCM herbal therapy combined with conventional western medicine for treatment of this disease.
The purpose of this multi-center perspective cohort study is to evaluate the relationship between TCM herbal therapy and survival outcomes in patients with advanced colorectal cancer.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
384
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
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Beijing
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Beijing, Beijing, China, 100091
- Oncology Department of Xiyuan Hospital of China Academy of Chinese Medical Sciences
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Contact:
- Yu Wu, M.D.
- Phone Number: 86 10 62835438
- Email: wy713@vip.sina.com
-
-
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
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
the patients with advanced colorectal cancer and the tumor progressed after conventional chemotherapy
Description
Inclusion Criteria:
- histologically confirmed adenocarcinoma of the colon or rectum
- TNM classification of stage IV disease according to American Joint Committee on Cancer
- Between 18 and 80 years old
- Progression or inability undergone conventional chemotherapy (Conventional chemotherapy regimen containing fluorouracil, oxaliplatin, irinotecan based chemotherapy, and all the above regimen should be used before)
- Expected survival time is over 3 months
- Signed informed consent
Exclusion Criteria:
- serious non-malignant diseases such as heart, renal, and hepatic illnesses
- the presence of other types of malignancies
- The patients can not take medicine for intestinal obstruction
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Traditional Chinese and Western medicine combined group
|
TCM herbal treatment combine with anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)
|
Traditional Chinese medicine group
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TCM herbal treatment based on TCM syndrome differentiation,without any anti tumor therapy in Western Medicine
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Western medicine group
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Anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progress free survival
Time Frame: 3 years
|
3 years
|
Quality of life as assessed by FACT-C v4.0
Time Frame: 3 years
|
3 years
|
Tumor control rate
Time Frame: 3 years
|
3 years
|
TCM syndrome score
Time Frame: 3 years
|
3 years
|
Number of participants with treatment-related adverse events as assessed by Chinese version of CTCAE v4.0
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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
September 1, 2016
Primary Completion (Anticipated)
March 1, 2020
Study Registration Dates
First Submitted
September 23, 2016
First Submitted That Met QC Criteria
October 1, 2016
First Posted (Estimate)
October 4, 2016
Study Record Updates
Last Update Posted (Estimate)
October 4, 2016
Last Update Submitted That Met QC Criteria
October 1, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D161100005116002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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