Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study
|ClinicalTrials.gov Identifier: NCT00968799|
Recruitment Status : Terminated (poor patient accrual)
First Posted : August 31, 2009
Results First Posted : May 10, 2013
Last Update Posted : May 15, 2013
Most studies performing hyperthermic intraoperative intraperitoneal chemotherapy dose the cytotoxic drugs according to the body surface (like 50 mg/m² cisplatin) in analogy to systemic, intravenous chemotherapy (usually using the same dose). Although there seems to be a correlation between body surface and blood volume, the pharmacodynamics of drugs dosed by the body surface is still highly variable and thus dosing on the body surface is increasingly considered controversial for systemic administration.
For hyperthermic intraoperative intraperitoneal chemotherapy dosing by the body surface makes even less sense, since the aim is the highest possible drug concentration in the peritoneum without undue local and systemic toxicity. Furthermore, most studies using intraoperative chemotherapy vary the volume of the perfusate according to the size of the patient. Since the amount of cytotoxic drug is already fixed by the dosing on the body surface (amount [mg] = dose [mg/m²] x body surface [m²]) the effective concentration (mg/l) in the perfusate can vary considerably between patients. On the other hand pharmacokinetic analyses have shown that reducing the concentration of the cytotoxic drug in the perfusate reduces the efficacy even if the amount of the drug remains the same.
In this study the safety of a new dosing regime will be evaluated. The concentration of cisplatin in the perfusate will be held constant independent of body weight or size to achieve the highest effectiveness of the chemotherapy. The primary endpoint is the safety of the treatment. All patients should be able to receive full dose systemic carboplatin chemotherapy after completion the trial treatment.
|Condition or disease||Intervention/treatment||Phase|
|Epithelial Ovarian Cancer Fallopian Tube Carcinoma||Procedure: Hyperthermic intraoperative intraperitoneal chemotherapy Procedure: Cytoreduction Drug: Cisplatin||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2012|
Experimental: HIPEC treatment
Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) with cisplatin
Perfusion of the peritoneum 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.
Procedure: Hyperthermic intraoperative intraperitoneal chemotherapy
Perfusion of the peritoneum with 42°C warm 25 mg/l cisplatin solution.
Other Name: HIPECProcedure: Cytoreduction
Surgical removal of tumor nodules
including resection of organs infested with tumor
Cisplatin is applied as chemotherapy during surgery
- Fitness for Systemic Chemotherapy [ Time Frame: 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.
- Nephrotoxicity [ Time Frame: 6 weeks post operation ]glomerular filtration rate (GFR)
- Surgical Complications [ Time Frame: 6 weeks post operation ]any serious surgical event (Dindo scale >= III (reoperation required) or CTCAE grade >=3)
- Overall Survival [ Time Frame: 5 years ]
- Pharmacokinetics [ Time Frame: intraoperative and 1 week after surgery ]data not analysed due to poor accrual
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968799
|Department of Surgery, Cantonal Hospital St. Gallen|
|St. Gallen, Switzerland, 9007|
|Principal Investigator:||Markus Lüdin, MD||Cantonal Hospital St. Gallen, Department of Surgery|