Rectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 70; 2. Colonscopy: tumor below 12cm from dentate line; 3. Pathological diagnosis of adenocarcinoma; 4. Resectable tumor; 5. CXR/CT, abdominal ultrasound/CT exclude metastasis; 6. No history of previous gastrointestinal surgery; 7. Without complete bowel obstruction; 8. Good cardiopulmnoary functions; 9. Expectation survival period more than 6 months; 10. Karnofsky score more than 70; 11. WBC > 3.5*10^9/ml, PLT> 10*10^9/ml, T-Bil 50ml/min.; 12. Female patients in trails must under contraception. And patients who is menopause should be assureed for 12 months and pregnancy should be ruled out; 13. No other relevant diseases (ex: tumors in other sites or serious disease heart or central nervous system, CNS).
Exclusion criteria
Exclusion criteria: 1. Pathological diagnosis other than adenocarcinoma and mucinous carcinoma; 2. Uncontroled underlying diseases (unstable angina etc); 3. Previous history of immunosuppresive therapy (including corticosteroids therapy); 4. Past history or excisting other malignancy; 5. Difficulty in endure anesthesia and surgery; 6. Serious uncontroled infections; 7. Diseases of CNS or psyche which affect congnition including CNS metastasis; 8. Serious allergy history; 9. Serious pulmonary heart disease for example: acute myocardial infarction shorter than 6 months or congestive heart failure or symptomatic angina, coagulative function abnormal etc.; 10. Female of pregnant and lactation or patients who reject contraceptional therapy during treatment period; 11. MRI/EBUS/CT suggest unresectable tumors; 12. Preexcisting incomplete or complete bowel obstruction related to rectal cancer; 13. Hereditary nonpolyposis colorectal cancer (HNPCC) and familial adenomatous polyposis(FAP).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-years survival rate and OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-years DFS;Operation related mortality and complication related mortality;Lymph notes detection rate;Operation time, blood loss, complication rates, length of hospital stay and costs;Recurrence within 3 years; | — |
Countries
China