ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00689364
Recruitment Status : Unknown
Verified June 2011 by Ministry of Science and Technology of the People´s Republic of China.
Recruitment status was:  Active, not recruiting
First Posted : June 3, 2008
Last Update Posted : July 22, 2011
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

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.


Condition or disease
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).


Study Type : Observational
Estimated Enrollment : 480 participants
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
Study Start Date : April 2007
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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).



Primary Outcome Measures :
  1. The recurrence and metastasis rates for 1、2、3、4 and 5-year. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Survival index: the survival rate for1、2、3、4 and 5-year. [ Time Frame: one year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: June 2011

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