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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00689364

Enrollment

480

Registered

2008-06-03

Start date

2007-04-30

Completion date

2014-03-31

Last updated

2011-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Cohort Study, Colorectal Cancer, Traditional Chinese Medicine, Risk of recurrence and metastasis

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results