Aerosol chemo spray shows promise for Hard-to-Treat ovarian cancer
NCT ID NCT04811703
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for women with advanced ovarian, fallopian tube, or peritoneal cancer whose tumors did not shrink enough with standard chemotherapy. Researchers are testing a new method called PIPAC, which delivers chemotherapy as a pressurized spray directly into the abdomen, combined with standard IV chemo. The goal is to find the safest dose and see if this combination can make tumors removable by surgery. About 15 women will take part in this early-stage safety trial.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hôpital Claude Huriez - Chirurgie générale et digestive
RECRUITINGLille, France
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Hôpital Claude Huriez - Oncologie médicale
RECRUITINGLille, France
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Hôpital Lyon Sud - Chirurgie Digestive et Oncologique
RECRUITINGPierre-Bénite, 69495, France
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Hôpital Lyon Sud - Chirurgie Gynécologique et oncologique-obstétrique
RECRUITINGPierre-Bénite, France
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Hôpital Lyon Sud - Oncologie Médicale
RECRUITINGPierre-Bénite, France
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Hôpital de la Croix-Rousse
RECRUITINGLyon, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can heated chemotherapy during surgery extend life for peritoneal cancer patients?
- Lab-Grown tumor models may predict who benefits from heated chemotherapy
- Can Lab-Grown tumor models predict the best therapy for each patient?
- Can a pill boost the immune system to fight Hard-to-Treat cancers?
- Triple chemo cocktail aims to clear deadly bowel blockages in advanced stomach cancer
- Chemotherapy sprayed directly into the abdomen: a new attack on stubborn cancers