Overview

This trial is active, not recruiting.

Condition colorectal cancer
Sponsor Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborator Tokyo Medical and Dental University
Start date April 2009
End date March 2017
Trial size 2128 participants
Trial identifier NCT00918827, CDR0000642386, TMDU-TRICC0807, UMIN000002013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants of any age.

- Pathologically confirmed stage III colon adenocarcinoma - Curatively resected (R0) - Patients scheduled for treatment with fluorouracil-based post-operative adjuvant chemotherapy - Provided written informed consent - Synchronous or metachronous multiple cancers - Contraindications for fluorouracil-based chemotherapy - Patients who have initiated neo-adjuvant chemotherapy or radiotherapy prior to participating in this study - Ineligible patients according to the investigator's judgement

Additional Information

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)
Principal investigator Kenichi Sugihara, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Translational Research Informatics Center, Kobe, Hyogo, Japan.