Trial Outcomes & Findings for Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study (NCT NCT00968799)

NCT ID: NCT00968799

Last Updated: 2023-08-08

Results Overview

Are patients fit to receive six courses of systemic carboplatin chemotherapy after completion of trial. If chemotherapy starts within 3 months after surgery and at least 4 courses could be administered, patient is considered fit. If chemotherapy is stopped early for reasons clearly unrelated to study treatment (e.g. platinum resistance), patient is also considered fit.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: 3 months post operation
• Results posted on: 2023-08-08

Participant Flow

overall recruitment was poor. study was terminated after 6 patients (of 27 scheduled)

Participant milestones

Measure	HIPEC Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) Tumor nodules are removed surgically. If necessary infested organs like colon are resected (=cytoreduction). To destroy remaining tumor cells or invisible nodules the peritoneum is prefused with 42°C warm 25 mg/l cisplatin solution. Perfusion volume depends on body size (3 - 6 l). If cisplatin amount exceeds the equivalent of 62.5 mg/m² body surface, cisplatin is dosed by body surface (62.5 mg/m²)(safety margin). Perfusion is performed with the open or Coliseum technique for 90 min.
Overall Study STARTED	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

HIPEC Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) Tumor nodules are removed surgically. If necessary infested organs like colon are resected (=cytoreduction). To destroy remaining tumor cells or invisible nodules the peritoneum is prefused with 42°C warm 25 mg/l cisplatin solution. Perfusion volume depends on body size (3 - 6 l). If cisplatin amount exceeds the equivalent of 62.5 mg/m² body surface, cisplatin is dosed by body surface (62.5 mg/m²)(safety margin). Perfusion is performed with the open or Coliseum technique for 90 min.

Overall Study Advanced disease, HIPEC not applicable

2

Baseline Characteristics

Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study

Baseline characteristics by cohort

Measure	HIPEC n=6 Participants Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Switzerland	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post operation

Are patients fit to receive six courses of systemic carboplatin chemotherapy after completion of trial.

If chemotherapy starts within 3 months after surgery and at least 4 courses could be administered, patient is considered fit.

If chemotherapy is stopped early for reasons clearly unrelated to study treatment (e.g. platinum resistance), patient is also considered fit.

Outcome measures

Measure	HIPEC n=4 Participants Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
Fitness for Systemic Chemotherapy	4 participants

SECONDARY outcome

Timeframe: 6 weeks post operation

glomerular filtration rate (GFR)

Outcome measures

Measure	HIPEC n=4 Participants Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
Nephrotoxicity no nephrotoxicity (normal GFR)	2 participants
Nephrotoxicity CTCAE grade 1 nephrotoxicity (by GFR)	2 participants

SECONDARY outcome

Timeframe: 6 weeks post operation

any serious surgical event (Dindo scale >= III (reoperation required) or CTCAE grade >=3)

Outcome measures

Measure	HIPEC n=4 Participants Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
Surgical Complications	0 participants

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	HIPEC n=4 Participants Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
Overall Survival	26 months Interval 16.0 to 58.0

SECONDARY outcome

Timeframe: intraoperative and 1 week after surgery

data not analysed due to poor accrual

Outcome measures

Outcome data not reported

Adverse Events

HIPEC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	HIPEC n=4 participants at risk Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
Investigations hypokalemia	25.0% 1/4 • Number of events 1 • 30 days post surgery

Additional Information

Sascha Müller, MD

Cantonal Hospital St.Gallen

Phone: +41 71 494 1317

Email: ulrich.beutner@kssg.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place