Advanced Colorectal Cancer
Conditions
Interventions
Group 1:Surgery plus intraperitoneal raltitrexed and adjuvant chemotherapy
Group 2:Surgery plus intraperitoneal normal saline and adjuvant chemotherapy
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-70 years old male or female; 2) ECOG <= 1; 3) Histopathological diagnosis of colorectal cancer; 4) TNM stage is T4NxM0 or T3N+M0, and the tumor site is located in the colon or upper rectum; 5) Preoperative imaging evaluation that possibility of operation excision; 6) The laboratory test within 1 week before treatment meet the following criteria:White blood cell (WBC)= 4.0×10^9/L; Absolute count of blood neutrophil (ANC) =2.0×10^9/L; Platelet (PLT) =100×10^9/L; Hemoglobin (HB) =90g/L; Serum total bilirubin (TB)=1.5×ULN; aspartate aminotransferase (AST),alanine aminotransferase (ALT), serum alkaline phosphatase (ALP)= 2.5×ULN; Blood urea nitrogen (BUN),serum creatinine (Cr) = 1.5×ULN; Endogenous creatinine clearance (Cr) =60 ml/min (calculated using the Cockcroft-Gault formula); 7) Patients volunteer to participate in the study and sign informed consent, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Serious complications associated with inability to tolerate postoperative chemotherapy; 2. The patient has a history of other tumor,except for the treatment of carcinoma of the cervical carcinoma in situ and basal cell carcinoma or squamous carcinoma of the skin; 3. Accompanied by peptic ulcer, digestive tract motility obstruction, severe active gastrointestinal bleeding, digestive tract perforation; 4. Patients known to have a history of allergies to the drug components or metabolites of this regimen; 5. Patients have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; 6. Patients with any heart disease, including: (1) angina; (2) drug-treated or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any other heart disease that the researcher judges to be unsuitable for this study; 7. Pregnancy, breast-feeding women; Female patients who have fertility and have a positive pregnancy test or are unwilling to take effective contraceptive measures throughout the trial; 8. According to the investigator's judgment, there are serious concomitant diseases (including but not limited to high blood pressure, severe diabetes, active infection, thyroid disease, etc.) that are harmful to the safety of the patient or affect the patient's completion of the study; 9. Previous history of neurological or psychiatric disorders that may affect research informed or follow-up evaluation, such as major depression, epilepsy or dementia; 10. Participate in other clinical trials within 30 days prior to enrollment and receive study medications and any concomitant treatments containing research medications; 11. The researchers did not believe that the case was suitable for the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year peritoneal metastasis rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical complication rate;Perioperative blood toxicity;1 and 2 years peritoneal metastasis rate;recurrence type;3 years DFS;5 years OS; | — |
Countries
China
Contacts
Public ContactWang Xishan
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed