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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00689364
• Other study ID #: WJB730603
• Status: Active, not recruiting
• Phase: N/A
• First received: May 27, 2008
• Last updated: July 20, 2011
• Start date: April 2007
• Est. completion date: March 2014

Study information

• Verified date: June 2011
• Source: Ministry of Science and Technology of the People´s Republic of China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeNorway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: March 2014
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Recurrence

Locations

Country	Name	City	State
China	Xi-Yuan Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Science and Technology of the People´s Republic of China	National Research Centre of Complementary and Alternative Medicine, Norway

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The recurrence and metastasis rates for 1?2?3?4 and 5-year.		one year	Yes
Secondary	Survival index: the survival rate for1?2?3?4 and 5-year.		one year	Yes

External Links

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