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

Ministry of Science and Technology of the People´s Republic of China

Status: Unknown

Conditions: Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00689364

WJB730603

Details and patient eligibility

About

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.

Full 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).

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

480 participants in 2 patient groups

CTTCT+CWMT

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).

CWMT cohort

Description:

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