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

June 1, 2017 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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

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 Overview

Status

Completed

Conditions

Colorectal Cancer

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.

Study Type

Observational

Enrollment (Actual)

2128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- - Tokyo, Japan, 113-8519
    - Tokyo Medical and Dental University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pathologically confirmed stage III colon adenocarcinoma patients who are given treatment with fluorouracil-based post-opeartive adjuvant chemotherapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	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	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	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	Until the day on which an event reveals during the 5 year observational period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborators

Tokyo Medical and Dental University

Investigators

Principal Investigator: Kenichi Sugihara, MD, PhD, Tokyo Medical and Dental University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Ishiguro M, Kotake K, Nishimura G, Tomita N, Ichikawa W, Takahashi K, Watanabe T, Furuhata T, Kondo K, Mori M, Kakeji Y, Kanazawa A, Kobayashi M, Okajima M, Hyodo I, Miyakoda K, Sugihara K. Study protocol of the B-CAST study: a multicenter, prospective cohort study investigating the tumor biomarkers in adjuvant chemotherapy for stage III colon cancer. BMC Cancer. 2013 Mar 25;13:149. doi: 10.1186/1471-2407-13-149.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)