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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2014-03-31

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.

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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).

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CTTCT+CWMT

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).

No interventions assigned to this group

CWMT cohort

CWMT :with or without chemotherapy/or radiotherapy after the radical operation (R0) (according to the latest NCCN clinical guideline).

No interventions assigned to this group

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No