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Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer
NCT05659381 · View on ClinicalTrials.gov ↗
Study Summary
Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy given per standard institutional guidelines +/- bevacizumab on Day 1 every 21 days for 3-4 cycles. Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study. Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease \>1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC Arm will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (No HIPEC Arm) will receive postoperative standard chemotherapy after recovery from surgery. Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per standard institutional guidelines +/- bevacizumab for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing +/- bevacizumab until progression or 36 months (if no evidence of disease).
Conditions Studied
Interventions
- DRUG Cisplatin
- OTHER No treatment
Study Locations (20)
California
- City of Hope — Duarte
- University of California San Diego Moores Cancer Center — La Jolla
- Hoag Memorial Hospital Presbyterian — Newport Beach
- Stanford Ambulatory Surgery Center Lane Operating Room — Palo Alto
- Stanford Women's Cancer Center — Palo Alto
- Stanford Hospital — Palo Alto
Kansas
- University of Kansas Hospital — Kansas City
- University of Kansas Medical Center MOB — Kansas City
- University of Kansas Cancer Center Overland Park — Overland Park
- University of Kansas Indian Creek Breast Surgery — Overland Park
- University of Kansas Cancer Center Westwood — Westwood
- University of Kansas Clinical Research Center — Westwood
Florida
- Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center — Coral Gables
- University of Miami Hospital and Clinics - Deerfield Beach — Deerfield Beach
- University of Miami Hospital and Clinics — Miami
- Miami Cancer Institute — Miami
- Sylvester Comprehensive Cancer Center - Plantation — Plantation
Connecticut
- Smilow Cancer Hospital at Yale- New Haven — New Haven
- Yale University School of Medicine — New Haven
Colorado
- University of Colorado Hospital - Anshutz Cancer Pavilion — Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2024-03-08 |
| Est. Completion | 2034-08-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05659381
The ClinicalTrials.gov registry entry for NCT05659381 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GOG Foundation, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Stage IV Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions — of which Cisplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05659381 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Kansas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05659381 about?
NCT05659381 is a clinical study titled "Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer". Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy given per standard institutional guidelines +/- bevacizumab on Day 1 every 21 days for 3-4 cycles. Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be ...
What is the current status of trial NCT05659381?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2024-03-08. Estimated completion is 2034-08-01.
What conditions does trial NCT05659381 study?
This clinical trial studies the following conditions: Stage IV Ovarian Cancer, Stage III Ovarian Cancer, Stage III Primary Peritoneal Cancer, Stage IV Primary Peritoneal Cancer, Stage III Fallopian Tube Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05659381?
The interventions under investigation include: Cisplatin (DRUG), No treatment (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05659381?
This trial is sponsored by GOG Foundation, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05659381 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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