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

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

Status: Completed

Conditions: Colorectal Cancer

Treatments: Drug: UFT adjuvant chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT00898846

CDR0000551714

TMDU-BRI-CC-05-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,111 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the colon or rectosigmoid

  • Stage II disease

• Must be registered on clinical trial TMDU-BRI-CC-05-01

• Must have resected tumor tissue available

• No hereditary colorectal cancer

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

PRIOR CONCURRENT THERAPY:

• Not specified

Trial design

1,111 participants in 2 patient groups

UFT adjuvant therapy group

Description:

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.

Treatment:

Drug: UFT adjuvant chemotherapy

Observation group

Description:

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.