Colorectal cancer
Conditions
Interventions
The treatment group:LBP lavage
The control group:Surgery alone
Sponsors
Chinese Academy of Medical Sciences Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male or female; 2. Histopathological diagnosis of colorectal cancer; 3. untreated patients,Previously did not receive chemotherapy or radiotherapy; 4. Preoperative imaging examination clinical staging was T4 or N+; 5. Physical condition ECOG PS 0-1; 6. The colonoscopy of the lower margin of the tumor was 10 cm. 7. Preoperative radiographic examination (chest pelvic abdominal enhancement CT or MRI) did not identify distant viscera or peritoneal metastasis; 8. Laboratory tests meet the following criteria: Bone marrow function:Absolute count of blood neutrophil (ANC) =1.5×10^9/L; Platelet (PLT) =100×10^9/L; Hemoglobin (HB) =90g/L; Liver function:Serum total bilirubin (TBIL), direct bilirubin (DBIL) = upper limit of normal (ULN)×1.5, alanine aminotransferase (ALT), aspartate aminotransferase; Kidney function: Serum creatinine (Cr) =ULN; Endogenous creatinine clearance (Ccr) =55 ml/min (calculated using the Cockcroft-Gault formula); 9. Women of childbearing age need to take effective contraceptive measures; 10. Patients or their legal representatives volunteer and sign informed consent forms.
Exclusion criteria
Exclusion criteria: 1.Major surgery or surgical injuries have not been healed in the first four weeks of the group. 2.In the past five years, malignant tumors with other histologic sources have been developed, except for the treatment of carcinoma of the cervical carcinoma in situ and basal cell carcinoma or squamous carcinoma of the skin. 3.Serious cardiovascular disease, including medical treatment can not control of high blood pressure (BP 160/95 mmHg or higher), unstable angina, over the past six months history of myocardial infarction, congestive heart failure > NYHA class II, severe arrhythmia and pericardial effusion, etc.; 4.Preoperative blood glucose control during the week was higher than 11.2mmol / L; 5.Severe infection requires intravenous antibiotics, antifungal or antiviral therapy; 6.Suffering from mental illness, poor compliance; 7.Bleeding in the first four weeks of the group was greater than that of CTCAE 3. 8.The researchers did not believe that the case was suitable for the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peritoneal transfer rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;OS;RFS;No retroperitoneal recurrence;The proportion of patients receiving adjuvant chemotherapy after surgery was compared;Two groups of postoperative complications; | — |
Contacts
Public ContactXiShan Wang and HaiTao Zhou
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical college
Outcome results
None listed