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Patients with first recurrent resistance ovarian cancer and disease progression with peritoneal carcinomatosis will undergo PIPAC procedure. The primary end point is to determine the clinical benefit rate (CBR) of a pressurized intraperitoneal aerosol chemotherapy with a combination of cisplatin and doxorubicin.
This study aims to investigate the therapeutic efficacy of PIPAC using cisplatin and doxorubicin in women with first recurrent resistance ovarian cancer and disease progression with peritoneal carcinomatosis. The primary objective of this study is to determine the Clinical Benefit Rate (CBR) according to RECIST/GCOG criteria after three cycles of PIPAC with PIPAC cisplatin and doxorubicin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIPAC | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin | Device | 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 10.5 mg/m2 body surface in 150 ml NaCl 0.9 % followed by doxorubicin at a dose of 2.1 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate (CBR) according to RECIST/GCOG criteria after three cycles of PIPAC with PIPAC cisplatin and doxorubicin | Evaluation of target lesions will be done as follows:
| 12-18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The median time to progression according to RECIST criteria after three cycles of PIPAC with cisplatin | From the last chemotherapy cycle to the first clinical-radiological signs of disease relapse | 1 Year |
| Fagotti score, as assessed by laparoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Sacred Heart | Rome | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24378877 | Result | Fagotti A, Petrillo M, Costantini B, Fanfani F, Gallotta V, Chiantera V, Turco LC, Bottoni C, Scambia G. Minimally invasive secondary cytoreduction plus HIPEC for recurrent ovarian cancer: a case series. Gynecol Oncol. 2014 Feb;132(2):303-6. doi: 10.1016/j.ygyno.2013.12.028. Epub 2013 Dec 27. | |
| 25701703 | Result |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 22, 2024 | |
| Reset | Aug 21, 2024 |
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| 1 Year |
| The degree of histological regression assessed by pathological review of repeated peritoneal biopsies | 1 Year |
| The proportion of women with a reduction of serum CA-125 of at least 50% after PIPAC | 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 | 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 | 1 year |
| Tempfer CB, Winnekendonk G, Solass W, Horvat R, Giger-Pabst U, Zieren J, Rezniczek GA, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy in women with recurrent ovarian cancer: A phase 2 study. Gynecol Oncol. 2015 May;137(2):223-8. doi: 10.1016/j.ygyno.2015.02.009. Epub 2015 Feb 18. |
| 24849521 | Result | Vizzielli G, Costantini B, Tortorella L, Petrillo M, Fanfani F, Chiantera V, Ercoli A, Iodice R, Scambia G, Fagotti A. Influence of intraperitoneal dissemination assessed by laparoscopy on prognosis of advanced ovarian cancer: an exploratory analysis of a single-institution experience. Ann Surg Oncol. 2014 Nov;21(12):3970-7. doi: 10.1245/s10434-014-3783-6. Epub 2014 May 22. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 22, 2024 | Aug 21, 2024 |