Study of Biomarkers in Tissue Samples of Patients With Stage III Colon Cancer Treated With Adjuvant Chemotherapy Comprising Fluorouracil-Based Regimens(B-CAST)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Enrollment
- 2128
- Locations
- 1
- Primary Endpoint
- Disease-free survival
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer who have undergone surgery and chemotherapy may help doctors predict how well patients will respond to treatment.
PURPOSE: This research study is looking at tumor samples from patients with stage III colon cancer who have undergone surgery and chemotherapy.
Detailed Description
OBJECTIVES: * Identify predictive factors of efficacy and safety of adjuvant chemotherapy comprising fluorouracil-based regimens in patients with stage III colon cancer. * Investigate possibility of "personalized treatment" with adjuvant chemotherapy based on the predictive factors identified. OUTLINE: Patients' tumor tissue samples are collected for protein expression levels of thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), VEGF, EGFR, mRNA-expression levels of TP, DPD, thymidylate synthase (TS), and orotate phosphoribosyl transferase (OPRT) by ELISA, Human Duo Set, and RT-PCR assays. Patients' enzyme expression levels are compared with their clinical data.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Disease-free survival
Time Frame: Until the day on which an event reveals during the 5 year observational period
Relapse-free survival
Time Frame: Until the day on which an event reveals during the 5 year observational period
Relationship between expression levels of enzymes and disease-free survival, relapse-free survival, and overall survival
Time Frame: 5 years after the end of registration
Relationship between expression levels of enzymes and adverse effects
Time Frame: 5 years after the end of registration