locally advanced rectal cancer
Conditions
Interventions
Chemoradiaotherapy TS-1: TS-1 is administered orally twice daily at a dose of 80-120 mg/day on Days 1-5, 8-12, 22-26, 29-33. Oxaliplatin: Oxaliplatin is administered intravenously at a dose of 50 mg
Sponsors
PerSeUS:Perpetual Study estimated-by United Sections in Gifu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Main lesion of the tumor is located at the Ra or Rb 2) Histologically confirmed rectum adenocarcinoma (tub1/tub2) 3) Clinical stage T3 or T4 (any N) 4) Possible to R0 resection 5) Without metastases 6) Age of 20 to 80 years 7) An Eastern Cooperative Oncology Group performance status of 0 or 1 8) No prior therapy (radiotherapy, chemotherapy and endocrine therapy) 9) Sufficient organ function as below : 1. WBC: >=3,000/mm3 and <=12,000/mm3 2. Neutrophil: >=1,500/mm3 3. Platelet: >=100,000/mm3 4. Hemoglobin: >=9.0g/dL 5. AST, ALT: <=100IU/L 6. Serum total bilirubin: <=2.0mg/dL 7. Serum creatinine: <=1.2mg.DL 8. Creatinine clearance: >= 60mL/min 10) Adequate oral intakes 11) Written informed concent
Exclusion criteria
Exclusion criteria: 1) History of Severe drug allergy 2) Active infections (over 38.0 degree) 3) Severe concurrent disease (interstitial pneumonitis or pulmonary fibrosis, poorly controlled diabetes, renal failure or hepatic failure) 4) Severe aberration of electrocardiogram, schemic heart disease, arrhythmia, cardiac infarction or heart failure. 5) Sensory neuropathy 6) Watery diarrhea 7) Massive pleural effusion or ascites 8) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less) 9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy 10) Current use of flucytosine 11) Positive hepatitis-B antigen 12) Physician concludes that the patient's participation in this trial is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological effect | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate R0 resection rate Disease free survival Overall survival Local recurrence rate Distant recurrence rate Safety Relative Dose Intensity | — |
Countries
Japan
Contacts
Public ContactTakao Takahashi
Gifu University graduate school of medicine Department of surgical oncology
Outcome results
None listed