ovarian cancer
Conditions
Interventions
Control:Day1:paclitaxel (PTX) 175mg/m2 (according to the specific circumstances of drug dose adjustment range <=5%), continuous intravenous infusion 3H
Day1 or Day2:carboplatin (AUC=5), intravenous drip.
Treatment:Day1:paclitaxel liposome (Liposomal paclitaxel) 175mg/m2 (according to the specific circumstances of drug dose adjustment range <=5%), continuous intravenous infusion 3H
Sponsors
Chongqing Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participated in the study and signed the informed consent; 2. aged from 18 to 75 years old; 3. cancer confirmed by pathology and /or cytology; 4. the scope of cytoreductive surgery is complete hysterectomy, double appendix, omentum, appendix and / or lymph node resection and excision of other parts of the naked eye; 5. patients need to recover from the side effects of previous treatment (surgery, neoadjuvant chemotherapy)to =6 months; 9. hemoglobin>=80g/L, WBC>=3x10^9/L,granulocyte>=1.5x10^9/L, platelet>=80x10^9/L; 10. serum bilirubin(TBIL)<=1.5 ULN,alkaline phosphatase (ALK), glutamic oxalacetic transaminase (AST) and alanine aminotransferase(ALT)<=2.5 ULN or <=5 ULN (liver metastasis); serum creatinine<=1.5 ULN.
Exclusion criteria
Exclusion criteria: 1. the surgical-pathological stage not be II - IV stage; 2. the pathological types were non epithelial ovarian,fallopian tube and peritoneum carcinoma; 3. participants with ovarian metastatic carcinoma; 4. failure to obtain satisfactory cytoreductive surgery. The definition of satisfactory cytoreductive surgery is invisible tumor or maximum residual tumor nodule diameter 2 level NCI-CTCAE, 4.03 Edition), active tuberculosis, and known or self prosecutions of HIV infection or active hepatitis B or hepatitis C; 10. combined severe respiratory system, blood system disease, obstinate dysentery or intestinal spasm, intestinal obstruction, or poor control of diabetes; 11. participants combined with uncontrolled hypertension of grade 2 or above (SBP >160 mmHg or DBP> 100 mmHg), congestive heart failure on NYHA grade III or above unstable angina or poor control of the arrhythmiacirculatory system diseases such as myocardial infarction were found within the first 6 months of the group; 12. have a history of drug allergy, especially those who have been allergic to research drugs and similar drugs in the past; 13. pregnant, breast-feeding women, and women of childbearing age who reject contraception during the treatment period; 14. the history of other primary malignant tumors other than the ovarian (fallopian tube and peritoneum) carcinoma; 15. any other serious complications or functional disorders of organ system which judged by the researchers that it will affect the safety of the subjects or the evaluation of interfering drug test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life assessment;Safety; | — |
Countries
China
Contacts
Public ContactQi Zhou
Chongqing Cancer Hospital
Outcome results
None listed