Study of Tumor Samples From Patients With Stage III Colon Cancer Who Have Undergone Surgery and Chemotherapy
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Study of Biomarkers in Tissue Samples of Patients With Stage III Colon Cancer Treated With Adjuvant Chemotherapy Comprising Fluorouracil-Based Regimens(B-CAST)|
- 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 ] [ Designated as safety issue: No ]
- Relationship between expression levels of enzymes and adverse effects [ Time Frame: 5 years after the end of registration ] [ Designated as safety issue: No ]
- Disease-free survival [ Time Frame: Until the day on which an event reveals during the 5 year observational period ] [ Designated as safety issue: No ]
- Relapse-free survival [ Time Frame: Until the day on which an event reveals during the 5 year observational period ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918827
|Tokyo Medical and Dental University|
|Tokyo, Japan, 113-8519|
|Principal Investigator:||Kenichi Sugihara, MD, PhD||Tokyo Medical and Dental University|