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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
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
First received: May 27, 2008
Last updated: July 20, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Estimated Enrollment: 480
Study Start Date: April 2007
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2012 (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

Locations
China, Beijing
Xi-Yuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing, China, 100091
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: Xi-Yuan Hospital, China Academy of Chinese Medical Sciences, Department of Oncology, Xi-Yuan Hospital
ClinicalTrials.gov Identifier: NCT00689364     History of Changes
Other Study ID Numbers: WJB730603
Study First Received: May 27, 2008
Last Updated: July 20, 2011
Health Authority: China: Ethics Committee
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Ministry of Science and Technology of the People´s Republic of China:
Cohort Study
Colorectal Cancer
Traditional Chinese Medicine
Risk of recurrence and metastasis

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Recurrence
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on May 16, 2013