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

July 20, 2011 updated by: Ministry of Science and Technology of the People´s Republic of China

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

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100091
        • Xi-Yuan Hospital, China Academy of Chinese Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival index: the survival rate for1、2、3、4 and 5-year.
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WJB730603

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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