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

• Conditions: Colorectal Cancer

• Registration Number: NCT00689364
• Lead Sponsor: Ministry of Science and Technology of the People´s Republic of China

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Status Verified: 2011-06
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-22
• Primary Completion: 2012-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The recurrence and metastasis rates for 1、2、3、4 and 5-year.	one year

Secondary Outcome Measures

Name	Time	Method
Survival index: the survival rate for1、2、3、4 and 5-year.	one year

Trial Locations

Locations (1)

Xi-Yuan Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China