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

NCT00689364 | Unknown DMC

• 1 other identifier: WJB730603
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The recurrence and metastasis rates for 1、2、3、4 and 5-year.

  one year

Secondary Outcomes (1)

• Survival index: the survival rate for1、2、3、4 and 5-year.

  one year

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patient who is diagnosed colorectal cancer by patho\& cytologic diagnosis since accepting radical operation within half a year.
• Stage II or III colorectal cancer.
• yr.
• Being able to participate and sign the informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ministry of Science and Technology of the People´s Republic of China: lead
• National Research Centre of Complementary and Alternative Medicine, Norway: collaborator

Study Sites (1)

Xi-Yuan Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100091, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Study Officials

• Yang Yufei, doctor

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: June 3, 2008
• Study Start: April 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2014
• Last Updated: July 22, 2011

Record last verified: 2011-06

Locations

CN (1)