MedPath

Identifying Prognostic Factors in Patients Receiving Tegafur-Uracil for Stage II Colon Cancer That Was Completely Removed By Surgery

Completed
Conditions
Colorectal Cancer
Interventions
Registration Number
NCT00898846
Lead Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Brief Summary

RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict which patients will respond to treatment.

PURPOSE: This laboratory study is looking at prognostic factors in patients receiving tegafur-uracil for stage II colon cancer that was completely removed by surgery.

Detailed Description

OBJECTIVES:

* Identify the prognostic factors in patients with curatively resected stage II colon cancer receiving adjuvant chemotherapy with tegafur-uracil.

* Identify predictive factors of chemosensitivity to this regimen in these patients.

OUTLINE: Available tumor tissue samples are analyzed by real-time reverse transcriptase-PCR for TS, DPD, TP, OPRT, VEGF, cyclooxygenase-2, and FPGS; by PCR for microsatellite instability and genomic deletions on chromosome arm 18q; and pathologically for tumor budding, Crohn's-like lymphoid reaction, category of extent of poor differentiation, and fibrotic cancer stroma. The candidate prognostic and predictive markers are analyzed for correlation with disease-free survival, relapse-free survival, and overall survival of patients.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1111
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
UFT adjuvant therapy groupUFT adjuvant chemotherapyUFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year. During protocol treatment, clinical findings and laboratory values are evaluated every month. After the completion of protocol treatment, patients are followed-up, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed.
Primary Outcome Measures
NameTimeMethod
mRNA levels9years

mRNA levels of patients are analyzed by the Danenberg tumor profile (DTP) method in the following indicators: thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), thymidine phosphorylase (TP), orotate phosphoribosyltransferase (OPRT), folylpolyglutamate synthetase (FPGS) vascular endothelial growth factor (VEGF), and cyclooxygenase-2 (Cox-2) mRNA levels.

Secondary Outcome Measures
NameTimeMethod
Analysis of microsatellite instability (MSI) and chromosomal instability (CIN)At enrollment

MSI and CIN (i.e., 18q LOH) are analyzed using paraffin embedded samples.

Histopathological examinationAt enrollment

Tumor budding, category of extent of poor differentiation, Crohn's-like lymphoid reaction, and fibrotic cancer stroma are analyzed using hematoxylin and eosin (H\&E) staining of paraffin embedded samples.

Trial Locations

Locations (152)

Nagoya Ekisaikai Hospital

🇯🇵

Nagoya, Aichi, Japan

Ban Buntane Houtokukai Hospital

🇯🇵

Nagoya, Aichi, Japan

Nagoya University Hospital

🇯🇵

Nagoya, Aichi, Japan

Nagoya University School of Medicine

🇯🇵

Nagoya, Aichi, Japan

Nagoya Midori Municipal Hospital

🇯🇵

Nagoya, Aichi, Japan

Aichi Prefectural Hospital

🇯🇵

Okazaki, Aichi, Japan

Yamamoto Kumiai General Hospital

🇯🇵

Noshiro, Akita, Japan

Hiraka General Hospital

🇯🇵

Yokote, Akita, Japan

Teikyo University Chiba Medical Center

🇯🇵

Ichihara, Chiba, Japan

Asahi General Hospital

🇯🇵

Inba-gunn, Chiba, Japan

Scroll for more (142 remaining)
Nagoya Ekisaikai Hospital
🇯🇵Nagoya, Aichi, Japan

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.