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NCT Number: NCT00918827

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokyo Medical and Dental University

Tokyo, 113-8519, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

<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

Treatment and study plan

Primary outcomes

  1. 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

  2. Relationship between expression levels of enzymes and adverse effects

    Time frame: 5 years after the end of registration

  3. Disease-free survival

    Time frame: Until the day on which an event reveals during the 5 year observational period

  4. Relapse-free survival

    Time frame: Until the day on which an event reveals during the 5 year observational period

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Tokyo Medical and Dental University

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Jun 11, 2009
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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