Status:
TERMINATED
Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study
Lead Sponsor:
Cantonal Hospital of St. Gallen
Conditions:
Epithelial Ovarian Cancer
Fallopian Tube Carcinoma
Eligibility:
FEMALE
18-70 years
Phase:
NA
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 ch...
Detailed Description
Disease Background: Between 1997 and 2001 the incidence of ovarian cancer in Switzerland was 15.8 per 100'000 women and ranks fifth among the cancer incidence in women. Nearly half of the patients di...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00968799
Start Date
February 1 2008
End Date
December 1 2012
Last Update
August 8 2023
Active Locations (1)
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1
Department of Surgery, Cantonal Hospital St. Gallen
Sankt Gallen, Switzerland, 9007