Study of Biomarkers in Tissue Samples of Patients With Stage III Colon Cancer Treated With Adjuvant Chemotherapy Comprising Fluorouracil-Based Regimens(B-CAST)
N/A
N/A
Both
Colorectal Cancer
Trial Information
Study of Biomarkers in Tissue Samples of Patients With Stage III Colon Cancer Treated With Adjuvant Chemotherapy Comprising Fluorouracil-Based Regimens(B-CAST)
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.
Inclusion Criteria
- 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Relationship between expression levels of enzymes and disease-free survival, relapse-free survival, and overall survival
Outcome Time Frame:
5 years after the end of registration
Safety Issue:
No
Principal Investigator
Kenichi Sugihara, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tokyo Medical and Dental University
Authority:
Japan: Institutional Review Board, Tokyo Medical and Dental University
Study ID:
CDR0000642386
NCT ID:
NCT00918827
Start Date:
April 2009
Completion Date:
Related Keywords:
- Colorectal Cancer
- adenocarcinoma of the colon
- stage III colon cancer
- Colonic Neoplasms
- Colorectal Neoplasms
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