Overview

This trial is active, not recruiting.

Condition colorectal cancer
Sponsor Ministry of Science and Technology of the People´s Republic of China
Collaborator National Research Centre of Complementary and Alternative Medicine, Norway
Start date April 2007
End date March 2012
Trial size 480 participants
Trial identifier NCT00689364, WJB730603

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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 :with or without chemotherapy/or radiotherapy after the radical operation (R0) (according to the latest NCCN clinical guideline).

Primary Outcomes

Measure
The recurrence and metastasis rates for 1、2、3、4 and 5-year.
time frame: one year

Secondary Outcomes

Measure
Survival index: the survival rate for1、2、3、4 and 5-year.
time frame: one year

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title 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
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Ministry of Science and Technology of the People´s Republic of China.