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

This study is currently recruiting participants.

Verified by Ministry of Science and Technology of the People´s Republic of China, June 2008

First Received: May 27, 2008 Last Updated: June 20, 2008 History of Changes

Sponsors and Collaborators:	Ministry of Science and Technology of the People´s Republic of China National Research Centre of Complementary and Alternative Medicine, Norway
Information provided by:	Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier:	NCT00689364

Purpose

Comprehensive therapy of traditional Chinese medicine (CTTCM) could relieve risk of recurrence and metastasis for stage II & III colorectal cancer, we 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.

Condition
Colorectal Cancer

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:

Observational

Study Design:

Cohort, Prospective

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

Further study details as provided by Ministry of Science and Technology of the People´s Republic of China:

Primary Outcome Measures:

the recurrence and metastasis rates for 1、2、3、4 and 5-year. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Survival index: the survival rate for1、2、3、4 and 5-year. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	620
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

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

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

CTTCT plus CWMT cohort in China:160 CWMT cohort in China:160 CWMT cohort in Norway:300

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689364

Contacts

Contact: Ge Jianzhong, doctor	086-13522799370	gejianzhongyq@tom.com
Contact: Wang Jianbing, doctor	086-13621382585	kingwjb@sohu.com

Locations

China
Xi-Yuan Hospital, China Academy of Chinese Medical Sciences	Recruiting
Beijing, China, 100091
Contact: Yang Yufei, Doctor 086-10-62882221 yyf93@vip.sina.com
Contact: Wu Yu, Master 086-10-62875599-6159 wy713@vip.sina.com
Principal Investigator: Wang Jiangbin, Doctor

Sponsors and Collaborators

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

National Research Centre of Complementary and Alternative Medicine, Norway

Investigators

Study Director:

Yang Yufei, doctor

Xi-Yuan Hospital, China Academy of Chinese Medical Sciences, China

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Department of Oncology, Xi-Yuan Hospital ( Xi-Yuan Hospital, China Academy of Chinese Medical Sciences )
Study ID Numbers:	WJB730603
Study First Received:	May 27, 2008
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00689364 History of Changes
Health Authority:	China: Ethics Committee; Norway: The National Committees for Research Ethics in Norway

Keywords provided by Ministry of Science and Technology of the People´s Republic of China:

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

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms

Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Recurrence
Colorectal Neoplasms

Additional relevant MeSH terms:

Disease Attributes
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on March 13, 2009