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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by (Responsible Party):
Sascha Müller, Cantonal Hospital of St. Gallen

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
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
Study Start Date : February 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Nephrotoxicity [ Time Frame: 6 weeks post operation ]
    glomerular filtration rate (GFR)

  2. Surgical Complications [ Time Frame: 6 weeks post operation ]
    any serious surgical event (Dindo scale >= III (reoperation required) or CTCAE grade >=3)

  3. Overall Survival [ Time Frame: 5 years ]
  4. Pharmacokinetics [ Time Frame: intraoperative and 1 week after surgery ]
    data not analysed due to poor accrual

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968799

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Department of Surgery, Cantonal Hospital St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
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Principal Investigator: Markus Lüdin, MD Cantonal Hospital St. Gallen, Department of Surgery
Additional Information:
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Responsible Party: Sascha Müller, Oberarzt, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT00968799    
Other Study ID Numbers: SGOV01
First Posted: August 31, 2009    Key Record Dates
Results First Posted: May 10, 2013
Last Update Posted: May 15, 2013
Last Verified: May 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:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antineoplastic Agents