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)

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• 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

<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

Study Plan

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	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

Collaborators and Investigators

• 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

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

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: June 9, 2009
• First Submitted That Met QC Criteria: June 9, 2009
• First Posted (Estimate): June 11, 2009

Study Record Updates

• Last Update Posted (Actual): June 2, 2017
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: adenocarcinoma of the colon; stage III colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: CDR0000642386; TMDU-TRICC0807 (Other Identifier: National Cancer Institute); UMIN000002013 (Registry Identifier: UMIN-CTR)