NCT03717610

Hyperthermic Intraperitoneal Chemotherapy for Treatment of Relapsed Ovarian Cancer

Feasibility of Intraoperative Given Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin During a Cytoreductive Surgery in Patients With Recurrent Ovarian, Peritoneal or Fallopian Tube Cancers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Uppsala University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Ovarian Cancer Recurrent

Interventions

Type	Name	Description
PROCEDURE	radical surgery with HIPEC	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).

Timeline

• Start date: 2018-10-04
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2018-10-24
• Last updated: 2021-10-08

Locations

1 site across 1 country: Sweden