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

This study has been terminated.
(poor patient accrual)
Information provided by (Responsible Party):
Sascha Müller, Cantonal Hospital of St. Gallen Identifier:
First received: February 12, 2008
Last updated: May 13, 2013
Last verified: May 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 Intervention
Epithelial Ovarian Cancer Fallopian Tube Carcinoma Procedure: Hyperthermic intraoperative intraperitoneal chemotherapy Procedure: Cytoreduction Drug: Cisplatin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study

Resource links provided by NLM:

Further study details as provided by Sascha Müller, Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

Enrollment: 6
Study Start Date: February 2008
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: HIPEC
Procedure: Cytoreduction

Surgical removal of tumor nodules

including resection of organs infested with tumor

Drug: Cisplatin
Cisplatin is applied as chemotherapy during surgery
Other Names:
  • cis-diamminedichloroplatinum(II)
  • cisplatinum
  • CDDP
  • Platinol

  Show Detailed Description


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient with histologically confirmed and recurrent epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma requiring secondary debulking. Last chemotherapy of primary treatment was finished at least 6 months before.
  • Patient must give written informed consent before registration
  • WHO/ECOG performance status 0 - 1
  • Age ≥18 years, ≤70 years
  • Adequate hematological values: leukocytes ≥3x10^9/l, thrombocytes ≥100x10^9/l
  • Adequate renal function. Obstructive hydronephrosis as a cause of "borderline" (30 - 45 ml/min) renal function should be investigated and treated prior to study entry.
  • Patient compliance and geographic proximity allow proper staging and follow-up.
  • FIGO III and IV

Exclusion Criteria:

  • Primary diagnosis of epithelial ovarian cancer, or primary treatment completed less than 6 months ago.
  • FIGO stage I + II
  • Distant and current metastases
  • WHO/ECOG performance status ≥2
  • Inadequate hepatic function: bilirubin >1.5x ULN (upper limit normal range) or ASAT/ALAT >2.5x ULN or AP >5x ULN
  • Psychiatric disorder precluding understanding of information of trial related topics or giving informed consent
  • Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to trial entry
  • Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes)
  • Known hypersensitivity to cisplatin
  • Any concomitant drugs contraindicated for use with the trial drugs according to the Swissmedic-approved product information
  • Dehydration
  • Impaired hearing or symptomatic peripheral neuropathy: ≥grade II NCI-CTCAEv3
  • Regular use of anti-epileptics
  Contacts and Locations
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Please refer to this study by its identifier: NCT00968799

Department of Surgery, Cantonal Hospital St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Principal Investigator: Markus Lüdin, MD Cantonal Hospital St. Gallen, Department of Surgery
  More Information

Additional Information:
Responsible Party: Sascha Müller, Oberarzt, Cantonal Hospital of St. Gallen Identifier: NCT00968799     History of Changes
Other Study ID Numbers: SGOV01
Study First Received: February 12, 2008
Results First Received: March 26, 2013
Last Updated: May 13, 2013

Keywords provided by Sascha Müller, Cantonal Hospital of St. Gallen:
Ovarian Neoplasms
Hyperthermia, Induced
Peritoneal Neoplasms
recurrent epithelial ovarian cancer
recurrent fallopian tube carcinoma

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Body Temperature Changes
Signs and Symptoms
Fallopian Tube Diseases
Antineoplastic Agents processed this record on August 21, 2017