Intensification Treatment of Ovarian Cancer by PIPAC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorMoscow Regional Oncological Dispensary
About this trial
The goal of this clinical trial is to learn whether repeated cisplatin-based PIPAC added to standard TC chemotherapy can improve outcomes in women aged 18-75 years with newly diagnosed FIGO IIIB-IIIC epithelial ovarian cancer and visually detectable peritoneal carcinomatosis. The main questions are whether repeated PIPAC increases the rate of complete surgical cytoreduction (CRS R0) and whether it improves disease control, survival outcomes, and safety compared with standard combined treatment including a single PIPAC procedure. Participants will undergo screening, intraoperative randomization, systemic chemotherapy, PIPAC procedures according to study arm, interval cytoreductive surgery, protocol-specified postoperative treatment if needed, and regular follow-up assessments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female, age 18-75 years.
Histologically verified ovarian cancer with peritoneal carcinomatosis.
FIGO stage IIIB or IIIC.
visually detectable peritoneal carcinomatosis.
Disqualifiers
Age > 75 years; ECOG 3-4; cachexia with BMI <= 16.
Severe concomitant disease in exacerbation or decompensation.
Extra-abdominal metastases, including metastatic pleuritis.
Mucinous ovarian carcinoma or another active malignant neoplasm, except malignancies in clinical remission for more than 2 years.
Trial design
Design model
Crossover
Treatments tested in this trial
PIPAC
Procedure/SurgeryPerformed laparoscopically under general anesthesia. Drug: cisplatin 30 mg/m² diluted in 180 mL normal saline Administration: * Capnoperitoneum established with carbon dioxide at a target pressure of 12-14 mmHg. * Flow settings depend on nozzle size: No. 150, 0.3-0.4 mL/s; No. 200, 0.7-0.8 mL/s. * Nebulizer selection depends on patient height and body-mass index; tense ascites is evacuated before treatment. * The aerosol flow is directed toward the largest free intraperitoneal space and away from hollow viscera, ligated vessels, and tumor beds. * Exposure time is maintained for exactly 30 minutes. * The abdomen is decompressed without aspirating the cytostatic solution, and no drain is left in place.
Treatment groups
160 Participants
are divided into 3 treatment groupsGroup A: Test group with 3 PIPAC proceduresExperimental treatment 1 intervention
Group B: Control group with 1 PIPAC procedureActive comparator 1 intervention
Group C: Crossover group with additional PIPACActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of complete surgical cytoreduction (CRS R0)
The proportion of participants who achieve complete surgical cytoreduction (CRS R0) at interval cytoreductive surgery.
Time frame
At interval cytoreductive surgery (Visit 4), approximately 9 to 12 weeks after randomizationSecondary outcomes
1
Overall survival
Time from randomization to death from any cause.
Time frame
From randomization through follow-up, assessed up to 2 years after completion of treatment2
Progression-free survival
Time from randomization to radiologic, clinical, or pathologic disease progression or death from any cause, whichever occurs first.
Time frame
From randomization through follow-up, assessed up to 2 years after completion of treatment3
Recurrence rate
Proportion of participants with documented disease recurrence after completion of protocol treatment.
Time frame
From completion of treatment through follow-up, assessed up to 2 years Recurrence rate is named among the secondary endpoints.4
Time to progression
Time from randomization to first documented disease progression.
Time frame
From randomization through follow-up, assessed up to 2 years after completion of treatmentOther outcomes
1
Peritoneal Cancer Index (PCI) response
Change in Peritoneal Cancer Index from baseline, categorized according to protocol-defined response criteria: complete response, partial response, stable disease, or progression.
Time frame
At baseline, before the second PIPAC procedure (approximately 6 weeks after randomization), and at interval cytoreductive surgery (approximately 9 to 12 weeks after randomization)2
Morphologic response in peritoneal and omental biopsy specimens
Histologic treatment response assessed in serial biopsy specimens using protocol-defined treatment-regression criteria.
Time frame
At baseline, before the second PIPAC procedure (approximately 6 weeks after randomization), and at interval cytoreductive surgery (approximately 9 to 12 weeks after randomization)3
Quality of life
Quality of life assessed using EORTC questionnaires during protocol follow-up.
Time frame
During follow-up, assessed every 3 months for 2 years after completion of treatment Quality of life is included as a protocol-defined follow-up assessment and is also listed among the correlative studies.Sponsors and contacts
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Source ClinicalTrials.gov