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

Colorectal Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918827
• Other study ID #: CDR0000642386
• Secondary ID: TMDU-TRICC0807UM
• Status: Completed
• Phase: N/A
• First received: June 9, 2009
• Last updated: June 1, 2017
• Start date: April 1, 2009
• Est. completion date: March 31, 2017

Study information

• Verified date: June 2017
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2128
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

<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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Japan	Tokyo Medical and Dental University	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan	Tokyo Medical and Dental University

Country where clinical trial is conducted

Japan, 

Outcome

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