CompletedNCT02735928PARROTUpdated Nov 15, 2023

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Applied to Platinum-Resistant Recurrence of Ovarian Tumor

An interventional study of Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin in Ovarian Epithelial Cancer Recurrent and Platinum-resistant, sponsored by Catholic University of the Sacred Heart. Completed at 1 site in Italy. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-15.

Sponsored by Catholic University of the Sacred Heart · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 40
Allocation: Not applicable
Ages: 18 Years to 70 Years
Sex: Female

Study summary

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.

Read the detailed description

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

Conditions studied

Ovarian Epithelial Cancer Recurrent
Platinum-resistant

In context

Lead sponsor

Catholic University of the Sacred Heart is the lead sponsor of 237 studies on the registry; 29 are open to participants now.

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Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: Female
Accepts healthy volunteers: No

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Inclusion criteria

Patients affected by first or second platinum resistant epithelial ovarian tumor recurrence.
ECOG-performance status ≤ 3.
Adequate respiratory, hepatic, cardiac, kidney and bone marrow function (absolute neutrophil count > 1500 / mm3, platelets > 150 000/μl, creatinine clearance > 60 mL / min according to Cockroft formula).
Patient-compliant and psychologically able to follow the trial procedures.

Exclusion criteria

Exclusion Criteria:

Non-epithelial ovarian cancer or borderline ovarian tumor.
Pregnancy or breastfeeding.
Patients affected by major depressive disorder even in treatment or minor mood disorders.
Patients with severe impairment of respiratory, hepatic or renal function.
Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease
Patients with bowel obstruction.
Inadequate bone marrow, liver, kidney function.
No clear-peritoneal disease at surgical exploration.
Patients with ascites >2000 cc (CT-Scan)
Patients who have already made third line chemotherapy.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 40 participants (actual)

Study arms

Experimental
PIPAC
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

Interventions

DevicePressurized 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 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).
Also known as: PIPAC

What researchers measure

Primary outcomes

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: * 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
Time frame: 12-18 weeks

Secondary outcomes

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
Time frame: 1 Year
Fagotti score, 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
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
Time frame: 1 year

Study locations

1 site

Catholic University of Sacred Heart
Rome, 00168, Italy

References and documents

Publications

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. PubMed 24378877 ↗
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. PubMed 25701703 ↗
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. PubMed 24849521 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2016 to primary completion in Jun 2021, 65 months.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 8, 2016
First posted: Apr 13, 2016
StartActual: Jan 2016
Primary completionActual: Jun 15, 2021
CompletionActual: Jun 16, 2022
Last update: Nov 15, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02735928
Lead sponsor: Catholic University of the Sacred Heart
Responsible party: Prof. Giovanni Scambia (Professor, Catholic University of the Sacred Heart) — Principal investigator
First posted: Apr 13, 2016
Start date: Jan 2016
Primary completion: Jun 15, 2021
Completion: Jun 16, 2022
Last update: Nov 15, 2023

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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