This trial is active, not recruiting.

Condition colorectal cancer
Treatments tegafur-uracil, polymerase chain reaction, reverse transcriptase-polymerase chain reaction, diagnostic laboratory biomarker analysis
Sponsor Tokyo Medical and Dental University
Start date October 2006
Trial size 1000 participants
Trial identifier NCT00898846, CDR0000551714, TMDU-BRI-CC-05-02


RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict which patients will respond to treatment.

PURPOSE: This laboratory study is looking at prognostic factors in patients receiving tegafur-uracil for stage II colon cancer that was completely removed by surgery.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Prognostic factors
time frame:
Predictive factors of chemosensitivity
time frame:

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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 PATIENT CHARACTERISTICS: - ECOG performance status 0-1 PRIOR CONCURRENT THERAPY: - Not specified

Additional Information

Official title Identification of the Prognostic Factors of Stage II Colon Cancer Patients Receiving Adjuvant Chemotherapy With UFT
Description 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. 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 information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).