Association of MSI, TS, DPD, MVD and EGFR With Chemosensitivity in Stage IV in Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2002 by National Taiwan University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173472
First received: September 12, 2005
Last updated: November 23, 2005
Last verified: July 2002
  Purpose

The present project will follow our previous phaseⅡ study of FOLFOX regimens for the treatment of stage Ⅳ colorectal cancer. We will recruit at least 200 patients for this study. The selection of patients will be based on rigorous eligibility criteria. The patients will be allocated based on the expression of each molecular marker (MSI, TS, DPD, MVD and EGFR) and the implementation of chemotherapy. For example, in the examination for the clinical implications of EGFR, the patients will be classified into four groups: EGFR(+) chemotherapy(+); EGFR(+) chemotherapy(-); EGFR(-) chemotherapy(+); EGFR(-) chemotherapy(-). Base on the analysis of this 2×2 table, we will clarify the prognostic significance of a specific molecular marker is due to whether the specific molecular marker predicts biological invasiveness and/or chemosensitivity. We believe the present study will have the following significance: (1)To further clarify the mechanisms for the carcinogenesis and progression of CRC; (2)To facilitate the development of novel chemotherapeutic agents; and (3) To gain the experience for the practice of evidence-based medicine.


Condition Intervention Phase
Colorectal Cancer
Drug: Chemotherapy
Phase 3

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Association of MSI, TS, DPD, MVD and EGFR With Chemosensitivity in Stage IV in Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 200
Study Start Date: July 2002
Estimated Study Completion Date: July 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients recruited met the following eligibility criteria: (1) The sporadic primary colorectal cancer could be palliatively resected and pathologically confirmed as adenocarcinoma; (2) The metastatic lesions were measurable but unresectable; (3) Karnofsky performance status was ≧50%; (4) The life expectancy was greater than 12 weeks; (5) WBC count was ≧4,000/μL, platelet count was ≧100,000/μL, serum bilirubin was ≦2.0 mg/dL, and serum glucose and electrolyte were normal.

Exclusion Criteria:

  • Patients with evident family history of colorectal cancer suggestive of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC) were excluded from this study. Moreover, patients with evident carcinosis peritonitis were excluded from this study because their bowel function could not be restored through palliative operation and their prognosis was considered as very poor.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00173472

Locations
Taiwan
Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jin-Tung Liang, M.D., Ph.D. Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00173472     History of Changes
Other Study ID Numbers: 9461700674
Study First Received: September 12, 2005
Last Updated: November 23, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
colorectal cancer, MSI, TS, DPD, EGFR, chemotherapy.

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 22, 2014