Intensification Treatment of Ovarian Cancer by PIPAC (NCT07514494) | Clinical Trial Compass
RecruitingPhase 2
Intensification Treatment of Ovarian Cancer by PIPAC
Russia160 participantsStarted 2025-04-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female, age 18-75 years.
* Histologically verified ovarian cancer with peritoneal carcinomatosis.
* FIGO stage IIIB or IIIC.
* visually detectable peritoneal carcinomatosis.
* Peritoneal metastatic involvement documented preoperatively by ultrasound, CT, MRI, PET-CT, or equivalent imaging.
* Ability to comply with protocol procedures and provide written informed consent.
Exclusion Criteria:
* 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.
* Pronounced adhesive disease of the abdominal cavity.
* Pregnancy or breastfeeding.
* Positive BRCA1 or BRCA2 status.
* Any condition precluding safe PIPAC or protocol execution, including hollow-organ perforation, gastrointestinal resection with anastomosis, or repair of a hollow-viscus defect.
* Refusal of treatment at any study stage.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of complete surgical cytoreduction (CRS R0)
Timeframe: At interval cytoreductive surgery (Visit 4), approximately 9 to 12 weeks after randomization