Comprehensive Therapy to Relieving the Risk of Recurrence and Metastasis for Colorectal Cancer

Study Overview
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Brief Summary
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Comprehensive therapy of traditional Chinese medicine (CTTCM) could relieve risk of recurrence and metastasis for stage II & III colorectal cancer, the investigators take this clinical trial with retrospective-prospective cohort study based on previous studies by international multi-center way. If the study shows a positive result, a pragmatic randomized controlled study with prospective, multi-centre and large-sample design will be given continuously. The aim is to establish recommended programs suggested by CTTCM strategies under conventional Western medicine therapy (CWMT) for stage II & III colorectal cancer.

Detailed Description
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CTTCM: taking TCM decoction based on syndrome differentiation daily and each dosage is decocted two times for intervention one year with a Chinese patent medicine at least. CWMT: with or without chemotherapy/or radiotherapy after the radical operation (R0) (according to the latest NCCN clinical guideline).

Official Title
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Retrospective-Prospective Cohort Study Effectiveness of Comprehensive Therapy of TCM to Relieving the Risk of Recurrence and Metastasis for Stage II & III Colorectal Cancer Based on Conventional Western Medicine Therapy

Conditions
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Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who is diagnosed colorectal cancer by patho& cytologic diagnosis since accepting radical operation within half a year. Stage II or III colorectal cancer. 18-75 yr. Being able to participate and sign the informed consent. Exclusion Criteria: Pregnant woman, Psychotic. Patient who put together with other cancer. Existed serious complaint and functional disturbance (impairment) with non-tumorous in arch-organ. Reactiveness cerebrovascular disease (CVD) . Uncontrolled infection and metabolic disease. One item of tumor marks is progressed, and it still is progressed when patient recheck. Tumor that it is neo-occurred in each organ or pelvic cavity or abdominal cavity without definite patho-quality.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| CTTCT+CWMT<br>CTTCM:taking TCM decoction based on syndrome differentiation daily and each dosage is decocted two times for intervention one year with a Chinese patent medicine at least. CWMT :with or without chemotherapy/or radiotherapy after the radical operation (R0) (according to the latest NCCN clinical guideline). | |
| CWMT cohort<br>CWMT :with or without chemotherapy/or radiotherapy after the radical operation (R0) (according to the latest NCCN clinical guideline). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recurrence and metastasis rates for 1、2、3、4 and 5-year. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival index: the survival rate for1、2、3、4 and 5-year. |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cohort Study, Colorectal Cancer, Traditional Chinese Medicine, Risk of recurrence and metastasis