💬In plain words
What the trial is, and whether it could suit you
Women with history of tumor response insufficient to allow complete cytoreductive surgery after three cycles of previous neoadjuvant systemic carboplatin-paclitaxel chemotherapy will be prospectively recruited in this trial. After signed consent and if unresectability is confirmed, patients will undergo three cycles of doxorubicin-cisplatin PIPAC chemotherapy associated with systemic carboplatin-paclitaxel chemotherapy (alternating PIPAC and intravenous chemotherapy sessions over 3 cycles of 4 weeks).
Since the 7th amendment of the study, sodium thiosulfate as nephrtoxicity prevention has been administered concurrently with each PIPAC chemotherapy
The primary objective of the study is to determine the maximum tolerated dose (MDT).
During cycle 1, limiting dose toxicity must be collected as soon as it is known.
Each patients will be treated at the dose recommended by the CRM (Continua
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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