Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer

Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer Combining Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Postoperative Intraperitoneal Chemotherapy (IPC)

Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer (NCT04282356) is a Phase 2 interventional studying Ovarian Cancer and Intraperitoneal Chemotherapy, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Clinicians postulate that it may be interesting to combine the two IntraPeritoneal (IP) treatments associated with a significant improvement of OC overall survival i.e. cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) and postoperative intraperitoneal chemotherapy (IPC) as an " intensive peritoneal " regimen in the initial management of stages III-IVA ovarian cancers. Performing a postoperative IPC may allow completing and extending the duration of the effect of HIPEC in decreasing the risk of peritoneal recurrence. HIPEC may also allow administering an early IP treatment on the residual microscopic disease during initial or interval surgery with an optimal access to the intraperitoneal cavity. Postoperative IPC will extend the HIPEC effect on unsterilized peritoneal microscopic residues with the aim of decreasing the risk of local recurrence. Performing HIPEC before IPC could allow limiting the number of postoperative IP courses needed. Nevertheless, this association questions its feasibility and tolerance, which should both be assessed in a phase II trial. Clinicians propose to conduct this feasibility study combining for the first time HIPEC with IPC as first-line treatment of ovarian cancer with peritoneal carcinomatosis to perform a peritoneal intensification.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Ovarian Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 55 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Ovarian Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients aged 18 to 75 years, - Patients with high-grade serous (high grade according to MD Anderson, grade II and III according to Silverman) ovarian or tubal or primitive peritoneal histologically proven cancer, - Initial laparoscopy confirming the histological type, evaluating the extent of the disease by PCI score and confirming the initial non-resectability, - Stage III B-C (FIGO 2014) or stage IVA with minimal or moderate pleural effusion (measured on a thoracic CT scanner, the largest thickness of which is less than 3 cm), - Complete interval cytoreduction surgery, - Indication of 3 to 4 cures of neoadjuvant chemotherapy based on the Carboplatin-Paclitaxel (carbo-taxol) combination, - The delay between the last course of NAT and the surgery must be between 4 and 8 weeks, - Hematologic function, blood count (hemoglobin) at least 10 g / dl; PNN ≥ 1 x 109 / L, platelet count at least 100 x 109 / L, - Total bilirubin ≤ 1.5 LSN, ALT or AST ≤ 3 ULN, - Absence of renal insufficiency (creatinine clearance ≤ 70 ml / min) according to the MDRD method, - willing to sign a consent form signed before any specific procedure under consideration, - Patients affiliated to the French social security scheme or equivalent. Who Should NOT Join This Trial: - Performance Index (WHO) ≥ 2, - Stage IV B or IV A with significant pleural effusion (measured on a thoracic CT scanner, the largest thickness of which is more than 3 cm), - Renal impairment (clearance \<70 ml / min) according to the MDRD method, - General contraindication to the realization of a tumor reduction surgery or HIPEC (contraindication or history allergic reaction to any treatments components), - Hepatic insufficiency (bilirubin \> 1.5 x normal, ASAT \& ALAT \> 3 x upper limit of normal), - Serious life-threatening co-existing condition at stake, - Cardio-respiratory pathology indicating hyper hydration, to be implemented for HIPEC, ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Patients aged 18 to 75 years, * Patients with high-grade serous (high grade according to MD Anderson, grade II and III according to Silverman) ovarian or tubal or primitive peritoneal histologically proven cancer, * Initial laparoscopy confirming the histological type, evaluating the extent of the disease by PCI score and confirming the initial non-resectability, * Stage III B-C (FIGO 2014) or stage IVA with minimal or moderate pleural effusion (measured on a thoracic CT scanner, the largest thickness of which is less than 3 cm), * Complete interval cytoreduction surgery, * Indication of 3 to 4 cures of neoadjuvant chemotherapy based on the Carboplatin-Paclitaxel (carbo-taxol) combination, * The delay between the last course of NAT and the surgery must be between 4 and 8 weeks, * Hematologic function, hemoglobin ≥ 10 g / dl; PNN ≥ 1 x 109 / L, platelets ≥ 100 x 109 / L, * Total bilirubin ≤ 1.5 LSN, ALT or AST ≤ 3 ULN, * Absence of renal insufficiency (creatinine clearance ≤ 70 ml / min) according to the MDRD method, * Informed consent signed before any specific procedure under consideration, * Patients affiliated to the French social security scheme or equivalent. Exclusion Criteria: * Performance Index (WHO) ≥ 2, * Stage IV B or IV A with significant pleural effusion (measured on a thoracic CT scanner, the largest thickness of which is more than 3 cm), * Renal impairment (clearance \<70 ml / min) according to the MDRD method, * General contraindication to the realization of a tumor reduction surgery or HIPEC (contraindication or history allergic reaction to any treatments components), * Hepatic insufficiency (bilirubin \> 1.5 x normal, ASAT \& ALAT \> 3 x upper limit of normal), * Serious life-threatening co-existing condition at stake, * Cardio-respiratory pathology indicating hyper hydration, to be implemented for HIPEC, * Patient who has already been treated with chemo-hyperthermia for ovarian cancer, * History of cancer, except basal cell carcinoma of the skin or carcinoma in situ of cervix having recurred within five years prior to entry into this trial, * Any severe untreated infectious disease, * Peripheral sensory neuropathy ≥ grade 2 at the inclusion time, * Patients whose regular follow-up is a priori impossible for psychological, family, social or geographical reasons, * Pregnant and / or nursing women, * Subjects under tutelage, curatorship or safeguard of justice.

Treatments Being Tested

DRUG

Intraperitoneal chemotherapy during surgery

During interval surgery the patient will undergo HIPEC (Cisplatin 100mg/m2, 1h 30 infusions with sodium thiosulfate renal protection). They will then receive postoperative IPC i.e intravenous and intraperitoneal administration (IV Paclitaxel, 135mg/m2 on D1, IP Carboplatin, AUC 6 on D1, and IP Paclitaxel, 60mg/m2 on D8) with at least 3 courses performed (up to 4-6 allowed).

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Institut du Cancer de Montpellier - Val d'Aurelle

Montpellier, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04282356), the sponsor (Institut du Cancer de Montpellier - Val d'Aurelle), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04282356 clinical trial studying?

Who can participate in NCT04282356?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04282356?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT04282356. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04282356. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.