Rectal cancer
Conditions
Interventions
Short-term group:Short-term radiotherapy (30Gy/10)with concurrent chemotherapy (Capecitabine 850-1000mg/m2 bid, continuous for 14 days during radiotherapy)
Long-term group:long-term radiotherapy (GTV1 50.6Gy/CTV 41.8Gy/22) with concurrent chemotherapy (Capecitabine 850-1000mg/m2 bid, continuous for 14 days during radiotherapy)
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathological diagnosis of rectal cancer; 2. Tumor lower than 10cm from anus by DRE; 3. Resectable tumor; 4. Clinical staging of T3-4 Nany or T2 N1-2 (evaluated by transrectal Bus and pelvic MRI etc); 5. No metastasis (including liver, lung,peritoneum and aortic lymph nodes etc.); 6. Karnofsky score more than 70; 7. WBC > 3.5*10^9/ml, PLT>10*10^9/ml, T-Bil 50ml/min.; 8. Signate of the informed consent; 9. Female patients in trails must under contraception; 10. Patients who is menopause should be assureed for 12 months and pregnancy should be ruled out; 11. No previous chemotherapy or radiotherapy; 12. No other relevant diseases (tumors in other sites or serious disease heart or central nervous system, CNS).
Exclusion criteria
Exclusion criteria: 1. Previous chemotherapy or radiotherapy or anti-tumor biological therapy 2. Previous history of immunosuppresive therapy (including corticosteroids therapy) 3. Previous attended other relative trails one month before the study 4. Preexisting colon cancer 5. Existing peripheral neuropathy (higher than WHO I grade) 6. Diseases of CNS or psyche which affect congnition including CNS metastasis 7. Serious allergy history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 years DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-years overall survival rate;Pathologic complete response (pCR) rate;Compliance of patients;Recurrence rate within 3 years after surgery;Ro resection rate;Sphincter preserving rate; | — |
Countries
China
Contacts
Public ContactJin Gu
Outcome results
None listed