Eligible patients must meet all of the following criteria to be included in the OVHIPEC-2 trial: | |
1. | signed and written informed consent |
2. | age ≥18 |
3. | histological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer, treated with primary complete cytoreduction, or primary cytoreduction with no more than 2.5 mm residual disease |
a. in case of extra-abdominal enlarged lymph nodes, representative cytology/histology or FDG-PET scan must be negative; | |
b. resectable, local bowel involvement, or spleen, or umbilical lesions are allowed; | |
c. in case no histological proof is available before surgery, patients can be randomized during surgery based on histological proof on intraoperative frozen section material | |
4. | fit for major surgery, WHO performance status 0–2 |
5. | adequate bone marrow function (hemoglobin level >5.5 mmol/L; neutrophils>1.5×109/L; platelets>100×109/L) |
6. | adequate hepatic function (ALT, AST, and bilirubin <2.5 times upper limit of normal) |
a. in case of Gilbert’s disease: bilirubin <5 times upper limit of normal | |
7. | adequate renal function (creatinine clearance using Cockcroft-Gault formula ≥60 mL/min) |
8. | baseline health-outcome questionnaire should be completed before randomization |
9. | able to understand the patient information and questionnaires |