Primary epithelial ovarian/fallopian tube carcinoma
Conditions
Interventions
experimental group:HIPEC was added in the initial exploration and interval debulking surgery(IDS)
control group:conventional therapy
Sponsors
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Primary epithelial/fallopian tube cancer was confirmed pathologically and estimated to be stage III~IV by preoperative imaging; 3. Untreated primary patients; 4. ECOG score 0-2; 5. Initial probe FOGOTTI score >= 6 points, unable to achieve satisfactory PDS; 6. WBC >= 4.0 x 10^9/L, hemoglobin >= 80g/L, platelet >= 80.0 x 10^9/L (after correction); Serum bilirubin <= normal upper limit, ALT and AST <= normal upper limit; Urea nitrogen (BUN) <= the upper limit of normal value, creatinine (Cr)<= the upper limit of normal value; 7. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Have a history of other malignant tumor diseases (except thyroid cancer) or have received anti-tumor treatment (including chemotherapy, radiotherapy and surgery); 2. Severe uncontrolled internal or surgical disease or acute infection; 3. Female patients who are pregnant or breastfeeding; 4. Gastrointestinal bleeding, perforation, intestinal obstruction or history of related diseases; 5. Extensive adhesion in the pelvic cavity; 6. All the treatments could not be completed in our hospital due to distance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| The 5-year disease-free survival rate (PFS); 2 - year OS and PFS ;changes in tumor load score at the initial exploration and IDS between the two groups, surgical satisfaction rate of IDS, and platinum-free interphase.;comparison of grade 3-4 adverse events and quality of life; | — |
Countries
China
Contacts
Public ContactFeng Weiwei
Department of Obstetrics and Gynecology, Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed