Lower rectal cancer
Conditions
Interventions
Capecitabine: at a dose of 1000mg/m2 twice daily on days 1-14, 22-35, 43-56 Oxaliplatin: at a dose of 130mg/m2 on days 1, 22 and 43 Surgical resection: 2-6 weeks after the completion of chemothera
Sponsors
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Surgical Oncology Group of Kyushu and Yamaguchi (SOGKY)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the rectum 2. Clinical stage II or III, determined by CT, MRI or EUS 3. Tumor with inferior edge located below peritoneal reflection 4. Without history of chemotherapy or radiotherapy for rectal cancer 5. Eastern Cooperative Oncology Group performance status of 0 or 1 6. Adequate organ function i) WBC >=3,000/mm3 ii) Neutrophil count >=1,500/mm3 iii) Platelet count >=100,000/mm3 iv) Serum bilirubin <=2.0mg/dl v) AST <=100IU/l vi) ALT <=100IU/l vii) Serum creatinine <=1.5mg/dl 7. Written study-specific informed consent
Exclusion criteria
Exclusion criteria: 1. Lateral node involvement 2. Cancerous fluid 3. Active infectious disease 4. Concomitant malignancy (within 5 years) and double cancer 5. Uncontrolled diabetic 6. Peripheral neuropathy 7. Serious lung disease 8. Clinically significant cardiac disease 9. Pregnant women and nursing mothers, possibly pregnant women, and men attempting to conceive a child 10. Other conditions judged ineligible by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, DFS, Local recurrence rate, Rate of sphincter-preservation, Pathologic response rate, Completion rate of postoperative adjuvant chemotherapy, acute toxicity, postoperative complications | — |
Countries
Japan
Contacts
Public ContactTatsuya Manabe,MD
Graduate School of Medical Sciences, Kyushu University Surgery and Oncology
Outcome results
None listed