Identifying Prognostic Factors in Patients Receiving Tegafur-Uracil for Stage II Colon Cancer That Was Completely Removed By Surgery
- 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
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description UFT adjuvant therapy group UFT adjuvant chemotherapy UFT 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
Name Time Method mRNA levels 9years 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
Name Time Method 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 examination At 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
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