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

NCT00173472 | Unknown

• 1 other identifier: 9461700674
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer, MSI, TS, DPD, EGFR, chemotherapy.

Interventions

Chemotherapy DRUG

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Microsatellite Instability

Interventions

Drug Therapy

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; Genomic Instability; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: July 1, 2002
• Study Completion: July 1, 2005
• Last Updated: November 24, 2005

Record last verified: 2002-07

Locations

TW (1)