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

This study has been terminated.
(poor patient accrual)
Sponsor:
Information provided by (Responsible Party):
Sascha Müller, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00968799
First received: February 12, 2008
Last updated: May 13, 2013
Last verified: May 2013
Results First Received: March 26, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Carcinoma
Interventions: Procedure: Hyperthermic intraoperative intraperitoneal chemotherapy
Procedure: Cytoreduction
Drug: Cisplatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
overall recruitment was poor. study was terminated after 6 patients (of 27 scheduled)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    HIPEC  
STARTED     6  
COMPLETED     4  
NOT COMPLETED     2  
Advanced disease, HIPEC not applicable                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HIPEC Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)

Baseline Measures
    HIPEC  
Number of Participants  
[units: participants]
  6  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  55  ± 6.6  
Gender  
[units: participants]
 
Female     6  
Male     0  
Region of Enrollment  
[units: participants]
 
Switzerland     6  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Fitness for Systemic Chemotherapy   [ Time Frame: 3 months post operation ]

2.  Secondary:   Nephrotoxicity   [ Time Frame: 6 weeks post operation ]

3.  Secondary:   Surgical Complications   [ Time Frame: 6 weeks post operation ]

4.  Secondary:   Overall Survival   [ Time Frame: 5 years ]

5.  Secondary:   Pharmacokinetics   [ Time Frame: intraoperative and 1 week after surgery ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Sascha Müller, MD
Organization: Cantonal Hospital St.Gallen
phone: +41 71 494 1317
e-mail: ulrich.beutner@kssg.ch


No publications provided


Responsible Party: Sascha Müller, Cantonal Hospital of St. Gallen
ClinicalTrials.gov 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
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic