Clinical trial NCT00689364: Comprehensive Therapy to Relieving the Risk of Recurrence and Metastasis for Colorectal Cancer
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: Cohort Study
Colorectal Cancer
Traditional Chinese Medicine
Risk of recurrence and metastasis
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
Collaborators: name: National Research Centre of Complementary and Alternative Medicine, Norway
First posted: 2008-06-03
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CTTCT plus CWMT cohort in China:160 CWMT cohort in China:160 CWMT cohort in Norway:300

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The recurrence and metastasis rates for 1、2、3、4 and 5-year.
timeFrame: one year
Secondary outcomes:
measure: Survival index: the survival rate for1、2、3、4 and 5-year.
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xi-Yuan Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Xi-Yuan Hospital, China Academy of Chinese Medical Sciences, China
name: Yang Yufei, doctor
role: STUDY_DIRECTOR
References: