Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Applied to Platinum-Resistant Recurrence of Ovarian Tumor (PARROT)
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|ClinicalTrials.gov Identifier: NCT02735928|
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : March 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Epithelial Cancer Recurrent Platinum-resistant||Device: Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin in Women With Recurrent Ovarian Cancer: an Open-label, Single-arm Phase I-II Clinical Trial|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||October 2021|
PIPAC stands for Pressurized IntraPeritoneal Aerosol Chemotherapies. Enrolled patients will undergo to explorative laparoscopy as usual and PC index will be determined according to Fagotti score (PIV). Pathological response will be determined by serial peritoneal biopsies. Then a pressurized aerosol containing cisplatin followed by doxorubicin will be applied via a nebulizer. The PIPAC procedure can be repeated after 4-6 weeks until progression or limiting toxicity
Device: Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin
After insufflation of a 12 mmHg of capnoperitoneum at 37 °C, two balloon trocars will be placed. Parietal biopsies will be taken and ascites (< 500cc) will be removed. A nebulizer will be connected to a high-pressure injector and will be inserted into the abdomen through a trocar. A pressurized aerosol containing cisplatin at a dose of 7.5 mg/m2 body surface in 150 ml NaCl 0.9 % followed by doxorubicin at a dose of 1.5 mg/m2 body surface in a 50 ml NaCl 0.9% solution will be applied via a nebulizer immediately. Then, the system will be kept in steady-state for 30 min (i.e.: application time).
Other Name: PIPAC
- Clinical Benefit Rate (CBR) according to RECIST/GCOG criteria after three cycles of PIPAC with PIPAC cisplatin and doxorubicin [ Time Frame: 12-18 weeks ]
Evaluation of target lesions will be done as follows:
- Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
- Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase
- The median time to progression according to RECIST criteria after three cycles of PIPAC with cisplatin [ Time Frame: 1 Year ]From the last chemotherapy cycle to the first clinical-radiological signs of disease relapse
- PCI, as assessed by laparoscopy [ Time Frame: 1 Year ]
- The degree of histological regression assessed by pathological review of repeated peritoneal biopsies [ Time Frame: 1 Year ]
- The proportion of women with a reduction of serum CA-125 of at least 50% after PIPAC [ Time Frame: 1 Year ]
- Evaluation of the Quality Of Life (QOL) on the basis of the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires [ Time Frame: 1 year ]Quality of life will be assess using the EORTC quality of life questionnaire core-36 (QLQC-30) and the ovarian cancer-specific quality of life questionnaire (QLQ-Ov28).These will be complete before and after the first, second, and third PIPAC applications
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): NCT02735928