Combination of PIPAC and systemic chemotherapy for advanced ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and maximum tolerated dose of pressurized intraperitoneal aerosol chemotherapy (PIPAC) combined with systemic chemotherapy in women with advanced ovarian cancer who have not responded sufficiently to prior treatments. Participants will receive three cycles of PIPAC chemotherapy alternating with intravenous chemotherapy over a period of 12 weeks. The study employs a Continual Reassessment Method (CRM) to guide dose escalation based on observed toxicities. The primary goal is to establish the recommended dose for future phase II trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years and ≤ 75 years;
* ECOG Performance Status 0-2;
* Histologically confirmed epithelial carcinoma of the ovary, fallopian tubes, or peritoneum, FIGO stage IIb to IVa, with a tumor response after three cycles of carboplatin-paclitaxel that does not correspond to disease progression but is insufficient to allow complete cytoreductive surgery, as assessed by the investigators after multidisciplinary tumor board discussion and validation;
* Adequate hematological function:

  * Absolute neutrophil count \> 1,500/mm³ (or 1.5 × 10⁹/L);
  * Hemoglobin ≥ 9.0 g/dL;
  * Platelet count \> 100 × 10⁹/L;
* Adequate renal and hepatic function:

  * Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or estimated glomerular filtration rate ≥ 60 mL/min/1.73 m² (CKD-EPI equation);
  * Total bilirubin ≤ 1.5 × ULN;
  * AST and ALT ≤ 1.5 × ULN (≤ 5 × ULN in patients with liver metastases);
* No unstable medical conditions, including myocardial infarction within 6 months prior to study entry, congestive heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, uncontrolled hypertension, uncontrolled psychiatric disorders, severe infection, peptic ulcer disease, or any condition that could be worsened by the study treatment or impair compliance, as judged by the investigator;
* Written informed consent obtained prior to any study-specific procedures;
* Patient affiliated with a national health insurance system.

Exclusion Criteria:

* Extra-peritoneal metastases whose location or extent precludes a potentially curative surgical procedure;
* Signs of bowel obstruction, bowel lesions with a high risk of intestinal perforation based on their location, or evidence of inflammatory bowel disease;
* Contraindication to intravenous carboplatin-paclitaxel chemotherapy, including known severe hypersensitivity to paclitaxel;
* Contraindication to PIPAC procedures, including:

  * Known hypersensitivity to cisplatin or other platinum compounds;
  * Known hypersensitivity to doxorubicin or other anthracyclines or anthracenediones;
  * Cardiac disease with myocardial insufficiency;
  * Uncontrolled coronary artery disease;
* Known hypersensitivity to sodium thiosulfate, sulfites, or any of its excipients;
* Administration of a live attenuated vaccine within 3 months prior to study treatment initiation or planned during the study;
* Pregnant or breastfeeding women;
* Individuals deprived of liberty, under guardianship, or subject to legal protection measures;
* Participation in another interventional research study with an ongoing exclusion period at inclusion, or in a study that could interfere with the results of the present study, as judged by the investigator;
* Inability to comply with study follow-up for geographical, social, or psychological reasons, as judged by the investigator.

Where it's running

• Hôpital Claude Huriez - Chirurgie générale et digestive
  Lille, France Recruiting
• Hôpital Claude Huriez - Oncologie médicale
  Lille, France Recruiting
• Hôpital de la Croix-Rousse
  Lyon, France Recruiting
• Hôpital Lyon Sud - Chirurgie Digestive et Oncologique
  Pierre-Bénite, France Recruiting
• Hôpital Lyon Sud - Chirurgie Gynécologique et oncologique-obstétrique
  Pierre-Bénite, France Recruiting
• Hôpital Lyon Sud - Oncologie Médicale
  Pierre-Bénite, France Recruiting

Study contacts

• Principal investigator: Justine ARQUILLIERE, MD — Hospices Civils de Lyon
• Study coordinator: Justine ARQUILLIERE, MD
• Email: justine.arquilliere@chu-lyon.fr
• Phone: 04 78 86 23 71

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.