Efficacy and Safety Evaluation of Traditional Chinese Medicine in the Treatment of Advanced Colorectal Cancer

Study Overview
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Brief Summary
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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.

Conditions
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Advanced Colorectal Cancer, Traditional Chinese Medicine

Intervention / Treatment
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* Other: Traditional Chinese medicine herbals
* Other: Integrated traditional Chinese and Western medicine
* Other: Western medicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Traditional Chinese and Western medicine combined group<br> | Other: Integrated traditional Chinese and Western medicine<br>* TCM herbal treatment combine with anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)<br>|
| Traditional Chinese medicine group<br> | Other: Traditional Chinese medicine herbals<br>* TCM herbal treatment based on TCM syndrome differentiation，without any anti tumor therapy in Western Medicine<br>|
| Western medicine group<br> | Other: Western medicine<br>* Anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival |  | 3 years | 
| Quality of life as assessed by FACT-C v4.0 |  | 3 years | 
| Tumor control rate |  | 3 years | 
| TCM syndrome score |  | 3 years | 
| Number of participants with treatment-related adverse events as assessed by Chinese version of CTCAE v4.0 |  | 3 years |