Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Identifying Prognostic Factors in Patients Receiving Tegafur-Uracil for Stage II Colon Cancer That Was Completely Removed By Surgery
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Biomarker/Laboratory analysis | Closed | 20 to 80 | Other | TMDU-BRI-CC-05-02 BRI-CC-05-02, NCT00898846 |
Objectives
- Identify the prognostic factors in patients with curatively resected stage II colon cancer receiving adjuvant chemotherapy with tegafur-uracil.
- Identify predictive factors of chemosensitivity to this regimen in these patients.
Entry Criteria
Disease Characteristics:
- Histologically confirmed adenocarcinoma of the colon or rectosigmoid
- Stage II disease
- Must be registered on clinical trial TMDU-BRI-CC-05-01
- Must have resected tumor tissue available
- No hereditary colorectal cancer
Prior/Concurrent Therapy:
- Not specified
Patient Characteristics:
- ECOG performance status 0-1
Expected Enrollment
1000Outcomes
Primary Outcome(s)Prognostic factors
Predictive factors of chemosensitivity
Outline
Available tumor tissue samples are analyzed by real-time reverse transcriptase-PCR for TS, DPD, TP, OPRT, VEGF, cyclooxygenase-2, and FPGS; by PCR for microsatellite instability and genomic deletions on chromosome arm 18q; and pathologically for tumor budding, Crohn's-like lymphoid reaction, category of extent of poor differentiation, and fibrotic cancer stroma. The candidate prognostic and predictive markers are analyzed for correlation with disease-free survival, relapse-free survival, and overall survival of patients.
Trial Lead Organizations
Tokyo Medical and Dental University
 | | | ||
| Kenichi Sugihara, MD, PhD, Protocol chair | |
| ||
| ||||
| Registry Information | ||
| ||
| Official Title | Identification of the Prognostic Factors of Stage II Colon Cancer Patients Receiving Adjuvant Chemotherapy with UFT | |
| ||
| Trial Start Date | 2006-10-01 | |
| ||
| Registered in ClinicalTrials.gov | NCT00898846 | |
| ||
| Date Submitted to PDQ | 2007-05-17 | |
| ||
| Information Last Verified | 2011-08-30 | |
Note: The purpose of some clinical studies is to help researchers learn more about how cancer cells grow and how drugs are used in the body. Cells and tissues collected from cancer patients may be used to detect new biomarkers that may be important in diagnosing and treating cancer in the future. The procedure or lab test described in this clinical study is intended to be carried out by clinical oncologists and researchers in carefully structured settings. Individual results obtained from these studies may not be made available to patients.
Back to Top
