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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Tokyo Medical and Dental University
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00918827
First received: June 9, 2009
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Relationship between expression levels of enzymes and adverse effects [ Time Frame: 5 years after the end of registration ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: Until the day on which an event reveals during the 5 year observational period ] [ Designated as safety issue: No ]
  • Relapse-free survival [ Time Frame: Until the day on which an event reveals during the 5 year observational period ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: April 2009
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918827

Locations
Japan
Tokyo Medical and Dental University
Tokyo, Japan, 113-8519
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Tokyo Medical and Dental University
Investigators
Principal Investigator: Kenichi Sugihara, MD, PhD Tokyo Medical and Dental University
  More Information

Additional Information:
No publications provided by Translational Research Informatics Center, Kobe, Hyogo, Japan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT00918827     History of Changes
Other Study ID Numbers: CDR0000642386, TMDU-TRICC0807, UMIN000002013
Study First Received: June 9, 2009
Last Updated: April 28, 2014
Health Authority: Japan: Institutional Review Board, Tokyo Medical and Dental University

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
adenocarcinoma of the colon
stage III colon cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014