Rectal cancer
Conditions
Interventions
UFT (300mg/m2/day) and UZEL (75mg/day) will be applied for patients with Stage II and III rectal cancer (Ra and Rb) who underwent curative resection for 28 days and these drugs will be stopped followi
Sponsors
Division of Surgical Oncology, Department of Surgery, Faculty of Medicine, Tottori University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histopathologically confirmed rectal cancer (Ra, Rb) 2)Patient who has received surgery with D2 or more lymph node dissection and whose final curability A (R0) 3)Stage II / III 4)No hepatic, peritoneal, or distant metastasis; no tumor cells in peritoneal fluid on cytologic analysis 5)Age>20. 6)No previous treatment(radiation therapy, chemotherapy, hormone therapy) for cancer except for surgical treatment. 7)Oral administration is possible within 8 weeks after surgical treatment. 8)Without any other severe diseases and adequate organ functions. Leu: >=4,000 /mm3, <=ULN Plt: >= 100,000 /mm3 T-bil: < 1.5 g/dL ALT: <=ULNx2.5 AST: <=ULNx2.5 Serum creatinine: <ULN Ccr: >= 30 mg/min 9)With written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients with severe surgical complication. 2)Phenytoin, warfarin potassium, or flucytosin administration. 3)Allergic more than and equal to grade3. 4)Patients with significant complications. 5)History of serious allergic reaction with UFT. 6)Lactating, pregnant or possibly pregnant women, and men who have willing to become partner's pregnant. 7)Patients with HIV,HBV. 8)Not appropriate for the study at the physician's assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3y RFS | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, Safety, treatment completion rate | — |
Countries
Japan
Contacts
Public ContactKeigo Ashida
Tottori University Division of Surgical Oncology
Outcome results
None listed