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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00918827

Enrollment

2128

Registered

2009-06-11

Start date

2009-04-01

Completion date

2017-03-31

Last updated

2017-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colon, stage III colon cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

\<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 \<

Exclusion criteria

\> * 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

Design outcomes

Primary

Measure	Time frame
Relationship between expression levels of enzymes and disease-free survival, relapse-free survival, and overall survival	5 years after the end of registration
Relationship between expression levels of enzymes and adverse effects	5 years after the end of registration
Disease-free survival	Until the day on which an event reveals during the 5 year observational period
Relapse-free survival	Until the day on which an event reveals during the 5 year observational period

Countries

Japan

Outcome results