This is a feasibility single-center study to investigate the tolerability, toxicity, quality of life, morbidity, mortality of the HIPEC treatment following cytoreductive surgery for treatment of recurrent ovarian, peritoneal, and fallopian tube cancers.
Ovarian cancer is the leading cause of gynecological cancer mortality; it is in 75% of cases detected at advanced stages. The standard treatment is cytoreductive surgery with removal of macroscopic tumor, and intravenous chemotherapy. Three randomized trials observed survival gain for ovarian cancer patients that received intraperitoneal chemotherapy after the optimal cytoreduction, however catheter-related complications made the procedure not feasible. A "one-time" hyperthermic intraperitoneal chemotherapy, HIPEC, is an established for peritoneal carcinosis in colorectal cancer, and recently two phase III randomised clinical studies observe survival gain also for ovarian cancer patients after surgery with HIPEC. Here the investigators, plan to investigate the HIPEC procedure following cytoreductive surgery for recurrent ovarian cancer, a progressed disease without any standard treatment established.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Straight after macroscopic radical cytoreductive surgery, an intraperitoneal hyperthermic perfusion using the open-abdomen technique will be performed with a single dose of cisplatin 100 mg/m2 administered for 90 minutes in the hyperthermic phase (41°C-43°C).
Uppsala University Hopsital
Uppsala, Sweden
RECRUITINGTreatment-related toxicities
Registration of the effects according to NCI CTCAEv4.0 guidelines.
Time frame: 3 months after surgery
Assessment of quality of life
EORTC C30 quality of life questionnaire
Time frame: before surgery, and 4 weeks, 3 months and 6 months after surgery
Assessment of quality of life in relation to ovarian cancer
EORTC OV28 quality of life questionnaire
Time frame: before surgery, and 4 weeks, 3 months and 6 months after surgery
Assessment of quality of Life in relation to eventually performed intestinal surgery
EORTC CR29 quality of life questionnaire
Time frame: before surgery, and 4 weeks, 3 months and 6 months after surgery
Morbidity
Rate of the high-grade 3 and 4 complications, according to the Clawien-Dindo scale
Time frame: 30 days after surgery
Mortality
Number of participants with lethal outcome
Time frame: 90 days after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.