NCT00918827

Study of Tumor Samples From Patients With Stage III Colon Cancer Who Have Undergone Surgery and Chemotherapy

Study of Biomarkers in Tissue Samples of Patients With Stage III Colon Cancer Treated With Adjuvant Chemotherapy Comprising Fluorouracil-Based Regimens(B-CAST)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,128 (actual)
• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Timeline

• Start date: 2009-04-01
• Primary completion: 2017-03-31
• Completion: 2017-03-31
• First posted: 2009-06-11
• Last updated: 2017-06-02

Locations

1 site across 1 country: Japan