Aerosol chemo spray shows promise for Hard-to-Treat ovarian cancer

NCT ID NCT04811703

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Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hôpital Claude Huriez - Chirurgie générale et digestive

    RECRUITING

    Lille, France

  • Hôpital Claude Huriez - Oncologie médicale

    RECRUITING

    Lille, France

  • Hôpital Lyon Sud - Chirurgie Digestive et Oncologique

    RECRUITING

    Pierre-Bénite, 69495, France

  • Hôpital Lyon Sud - Chirurgie Gynécologique et oncologique-obstétrique

    RECRUITING

    Pierre-Bénite, France

  • Hôpital Lyon Sud - Oncologie Médicale

    RECRUITING

    Pierre-Bénite, France

  • Hôpital de la Croix-Rousse

    RECRUITING

    Lyon, France

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