We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00918827
First Posted: June 11, 2009
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tokyo Medical and Dental University
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
  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)

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 ]
  • Relationship between expression levels of enzymes and adverse effects [ Time Frame: 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 ]
  • Relapse-free survival [ Time Frame: Until the day on which an event reveals during the 5 year observational period ]

Enrollment: 2128
Study Start Date: April 1, 2009
Study Completion Date: March 31, 2017
Primary Completion Date: March 31, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: National Cancer Institute )
UMIN000002013 ( Registry Identifier: UMIN-CTR )
First Submitted: June 9, 2009
First Posted: June 11, 2009
Last Update Posted: June 2, 2017
Last Verified: June 2017

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

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