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

Conditions

Intervention / Treatment

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100091
        • Oncology Department of Xiyuan Hospital of China Academy of Chinese Medical Sciences

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

14 years to 76 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
Other: Integrated traditional Chinese and Western medicine
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
Other: Traditional Chinese medicine herbals
TCM herbal treatment based on TCM syndrome differentiation，without any anti tumor therapy in Western Medicine
Western medicine group
Other: Western medicine
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.

Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Collaborators

Beijing Municipal Science & Technology Commission

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.

General Publications

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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