Rectal cancer
Conditions
Interventions
Group 1 :postoperative chemoradiotherapy
Group 2:postoperative chemotherapy
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old; 2. Pathologically confirmed rectal adenocarcinoma; 3. Preoperative colonoscopy showed that the lower edge of the tumor was less than 15 cm from the anal verge; 4. Preoperative MRI showed that the lower edge of the tumor was located below the line connecting the promontory of the sacrum and the upper edge of the pubic symphysis; 5. The lower edge of the tumor is located on the peritoneal reflex (judged by comprehensive preoperative MRI and intraoperative exploration results); 6. The postoperative pathological stage is stage III (pT1-4aN+M0); 7. The patient did not receive preoperative radiotherapy and chemotherapy; 8. The primary tumor of rectal cancer has been radically resected (near resection margin, distal resection margin and peripheral resection margin are all negative); 9. ASA score = 1.5 x 10^9/L; (2) Platelets >= 100 x 10^9/L; (3) Hemoglobin >= 90 g/L (no packed red blood cell transfusion within 2 weeks); (4) International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (APTT) = 50 mL/min; (6) Serum total bilirubin <= 1.5 x ULN; (7) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) <= 2.5 x ULN; 11. Patients can understand the research protocol and are willing to participate in this study, and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of malignant tumor; 2. Previous medical history of pelvic radiotherapy; 3. Synchronous or heterochronous multiple primary cancers of the large intestine; 4. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgical resection; 5. Those with a history of colorectal surgery; 6. MDT discusses that the patient is not suitable for entering the study; 7. ASA score IV or V; 8. Pregnant or lactating women; 9. Severe mental illness history; 10. Continuously received systemic steroid therapy within 1 month; 11. Patients with the following situation within 12 months prior to participating in the study: active coronary artery disease, severe/unstable angina pectoris or newly diagnosed angina pectoris, myocardial infarction, cerebral hemorrhage, cerebral infarction (including transient ischemic attack), pulmonary embolism or deep vein thrombosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year local recurrence free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate;3-year disease free survival rate;Improvement in quality of life;Incidence of chemoradiotherapy related adverse events; | — |
Countries
China
Contacts
Public ContactXianhua Gao
Shanghai Changhai Hospital
Outcome results
None listed