Identifying Prognostic Factors in Patients Receiving Tegafur-Uracil for Stage II Colon Cancer That Was Completely Removed By Surgery
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Identification of the Prognostic Factors of Stage II Colon Cancer Patients Receiving Adjuvant Chemotherapy With UFT|
- mRNA levels [ Time Frame: 9years ] [ Designated as safety issue: No ]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.
- Analysis of microsatellite instability (MSI) and chromosomal instability (CIN) [ Time Frame: At enrollment ] [ Designated as safety issue: No ]MSI and CIN (i.e., 18q LOH) are analyzed using paraffin embedded samples.
- Histopathological examination [ Time Frame: At enrollment ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
|Study Start Date:||October 2006|
|Study Completion Date:||September 2016|
|Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
UFT adjuvant therapy group
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.
Drug: 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.
Other Name: Adjuvant chemotherapy with tegafur-uracil
Patients are followed-up without adjuvant treatment, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898846
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|Study Chair:||Kenichi Sugihara, MD, PhD||Tokyo Medical and Dental University|