Heated chemo could boost ovarian cancer survival

NCT ID NCT05659381

Disease control Sponsor: GOG Foundation Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether giving heated chemotherapy directly into the abdomen during surgery helps people with advanced ovarian, fallopian tube, or primary peritoneal cancer. About 220 participants will be randomly assigned to receive either heated chemo plus standard treatment or standard treatment alone. After surgery, both groups will get maintenance therapy to keep cancer from returning.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Cisplatin (heated chemotherapy)
What this could lead to: If successful, this could improve how long people with advanced ovarian cancer live without their cancer growing back.
What could go wrong: This is a phase 3 trial, but results are not yet known. The heated chemo may cause more side effects, and not everyone may benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 220 people

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

Started

Mar 2024

Expected to finish

Aug 2034

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: 1. Patients must have a pathologic diagnosis of high grade serous or endometroid epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, FIGO stage III or IV documented on CT scan/MRI, must be recommended and agree to undergo platinum-based neoadjuvant chemotherapy with or without physician choice bevacizumab (3-4 cycles allowed, with bevacizumab held for at least 28 days preoperatively) and are considered candidates for (and planned to have) interval cytoreductive surgery (iCRS) followed by chemotherapy and niraparib maintenance as determined by the enrolling investigator. Patients may continue bevacizumab after a minimum of 28 days post iCRS and during niraparib maintenance per local standard. 2. Patients with stage IV disease must have complete response of extra-abdominal disease on preoperative imaging (e.g. pleural effusion, mediastinal, inguinal, supraclavicular lymphadenopathy, or other extra-abdominal metastases) or be deemed resectable with iCRS. 3. Patients must have HRD/LOH positive tumors. Patients with germline or somatic BRCA or other similar mutations (RAD51C, RAD51D, BRIP1, BARD) are not required to have HRD/LOH testing. Patients without BRCA or germline mutations must have HRD/LOH testing using Myriad myChoice®/Foundation Medicine/Caris Life Sciences platforms. HRD test results must be available prior to registration to meet entry criteria. 4. Patients must have R0 (no gross/visible residual disease) or R1 (gross/visible residual disease ≤ 1.0 cm in the longest diameter) following iCRS and prior to randomization. 5. Patient must have adequate bone marrow and organ function: Bone marrow function: Hemoglobin ≥ 8.5 g/dL. Absolute neutrophil count (ANC) ≥ 1,500/mm3. Platelets ≥ 100,000/mm3. Renal function: Creatinine ≤ 1.3mg/dl OR Calculated creatinine clearance (≥ 30 mL/min/1.73 m2) per National Kidney Foundation guidelines and NHANES III Hepatic function: Bilirubin ≤ 1.5 times ULN. ALT ≤ 3 times the ULN. AST ≤ 3 times the ULN. Neurologic function: Peripheral neuropathy ≤ CTC AE grade 2. 6. Patients must have an ECOG performance status of 0 or 1. 7. Patient must be age \> 18. 8. Patients must have a life expectancy \> 3 months. 9. Patients of childbearing potential must have a negative serum pregnancy test within 28 days prior to iCRS and must be practicing an effective form of contraception (with failure rate \<1% per year) during the study period and for 6 months following the last dose of niraparib. Patients of childbearing potential must consent to pregnancy testing prior to receiving niraparib and monthly thereafter for the duration of the study. Patients are considered postmenopausal and not of child-bearing potential if they are free from menses for \>1 year or surgically sterilized. 10. Patients must have normal blood pressure (BP) or adequately treated and controlled hypertension based on local standard of care (systolic BP ≤ 140 mmHg and diastolic ≤ 90 mmHg) prior to starting niraparib. 11. Patients receiving corticosteroids may continue as long as their dose is stable for at least 4 weeks prior to randomization. 12. Patients must agree to not donate blood during the study or for 90 days after the last dose of study treatment. 13. Patients with known human immunodeficiency virus (HIV) are allowed if they meet all the following criteria: 1. Cluster of differentiation 4 ≥350/µL and viral load \<400 copies/mL 2. No history of acquired immunodeficiency syndrome-defining opportunistic infections within 12 months prior to enrollment 3. No history of HIV associated malignancy for the past 5 years 4. Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV started \>4 weeks prior to study enrollment 14. Patient or a legally authorized representative must have signed an approved informed consent and authorization permitting the release of personal health information. Exclusion Criteria 1. Patients with low-grade serous, clear cell, mucinous, non-epithelial ovarian cancers and borderline tumors. 2. Patients who have received prior treatment for ovarian cancer other than the first 3-4 cycles of platinum based neoadjuvant chemotherapy. Prior neoadjuvant treatment with bevacizumab is allowed; bevacizumab must be held for 28 days prior to surgery. 3. Patients whose tumors are HRD/LOH negative. 4. Patients not eligible for iCRS based on evidence of progression of disease during neoadjuvant chemotherapy (documented on CT scan/MRI required within 35 days of iCRS). 5. Patients not eligible for iCRS based on medical co-morbidities as per the enrolling investigator. 6. Patients with stage IV disease without complete response of extra-abdominal disease on preoperative findings (e.g., pleural effusion, mediastinal, inguinal, supraclavicular lymphadenopathy, mesemchymal liver metastases or other extra-abdominal metastases) who are not deemed resectable with iCRS. 7. Patients with a history of Myelodysplastic Syndrome or Acute Myeloid Leukemia. 8. Patients who are pregnant or lactating. 9. Patients with a severe infection requiring IV antibiotics within 2 weeks of planned randomization. 10. Patients with other uncontrolled, intercurrent medical conditions. 11. Patient with metastatic disease to the central nervous system. 12. Patient with uncontrolled insulin dependent diabetes or pre-existing renal condition. 13. Patients with pre-existing hearing loss related to prior platinum-based chemotherapy. 14. Patients with Prior Reversible Encephalopathy Syndrome (PRES). 15. Patients with current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment). Severe hepatic impairment patients should be excluded. 16. Patients with any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels that is not related to ovarian cancer. 17. Patients with clinically significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, uncontrolled cardiac arrhythmia or unstable angina \<6 months to randomization, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident within 6 months). 18. Patients with an increased bleeding risk due to concurrent conditions (e.g., major injuries or major surgery within the past 28 days prior to study randomization and/or history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months). 19. Patients with known active hepatitis B (eg, hepatitis B surface antigen reactive) are excluded unless their HBV is stably controlled on nucleos(t)ide analogs (eg entecavir or tenofovir) which will be continued for the duration of the study. 20. Patient has had investigational therapy administered within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to study randomization. 21. Patient has received a live vaccine within 30 days of study randomization. COVID-19 vaccines that do not contain live viruses are allowed at any time during the study. 22. Patient has a diagnosis, detection, or treatment of another type of invasive cancer ≤ 2 years prior to initiating protocol therapy (except for basal or squamous cell carcinoma of the skin, cervical cancer in situ, and ductal cancer in situ (DCIS) that has been definitively treated). 23. Patients must not have had radiotherapy encompassing \> 20% of the bone marrow within 2 weeks of randomization; or any radiation therapy within 1 week prior to randomization.

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer fallopian tube neoplasm ovarian cancer ovarian carcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stage III fallopian tube cancer Stage III ovarian cancer Stage III primary peritoneal cancer Stage IV fallopian tube cancer Stage IV ovarian cancer Stage IV primary peritoneal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

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

Asplundh Cancer Pavilion
RECRUITING

Willow Grove, Pennsylvania, 19090, United States
Baylor College of Medicine Medical Center
RECRUITING

Houston, Texas, 77030, United States
City of Hope
RECRUITING

Duarte, California, 91010, United States
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
Duke Cancer Center
RECRUITING

Durham, North Carolina, 27710, United States
Duke Women's Cancer Care Raleigh
RECRUITING

Raleigh, North Carolina, 27607, United States
Forbes Hospital
RECRUITING

Monroeville, Pennsylvania, 15146, United States
Froedtert Memorial Lutheran Hospital & Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Hartford Hospital
RECRUITING

Hartford, Connecticut, 06102, United States
Hoag Memorial Hospital Presbyterian
RECRUITING

Newport Beach, California, 92663, United States
Holy Name Medical Center
RECRUITING

Teaneck, New Jersey, 07666, United States
Inova Schar Cancer Institute
RECRUITING

Fairfax, Virginia, 22031, United States
Jefferson Abington Hospital
RECRUITING

Abington, Pennsylvania, 19001, United States
Jefferson Hospital
RECRUITING

Jefferson Hills, Pennsylvania, 15025, United States
LSU Health New Orleans
RECRUITING

New Orleans, Louisiana, 70112, United States
Lankenau Medical Center/Mainline Medical Center
RECRUITING

Wynnewood, Pennsylvania, 19096, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55905, United States
Medical University of South Carolina (Hollings Cancer Center)
RECRUITING

Charleston, South Carolina, 29425, United States
Memorial Sloan-Kettering Cancer Center
RECRUITING

New York, New York, 10022, United States
Miami Cancer Institute
RECRUITING

Miami, Florida, 33176, United States
O'Quinn Medical Tower at McNair Campus
RECRUITING

Houston, Texas, 77054, United States
SCC at Lake University
RECRUITING

Mentor, Ohio, 44060, United States
Smilow Cancer Hospital at Yale- New Haven
RECRUITING

New Haven, Connecticut, 06511, United States
St. John Medical Center
RECRUITING

Westlake, Ohio, 44145, United States
Stanford Ambulatory Surgery Center Lane Operating Room
RECRUITING

Palo Alto, California, 94034, United States
Stanford Hospital
RECRUITING

Palo Alto, California, 94305, United States
Stanford Women's Cancer Center
RECRUITING

Palo Alto, California, 94304, United States
Sylvester Comprehensive Cancer Center - Plantation
RECRUITING

Plantation, Florida, 33324, United States
Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
RECRUITING

Coral Gables, Florida, 33146, United States
Texas Oncology - Central South
RECRUITING

Austin, Texas, 78758, United States
TriHealth Cancer Institute - Good Samaritan Hospital
RECRUITING

Cincinnati, Ohio, 45220, United States
TriHealth Cancer Institute- Thomas Comprehensive Care Center
RECRUITING

Cincinnati, Ohio, 45242, United States
UH Geauga Medical Center
RECRUITING

Chardon, Ohio, 44024, United States
UH Minoff Health Center at Chagrin Highlands
RECRUITING

Orange, Ohio, 44122, United States
University Hospitals Cleveland Medical Center
RECRUITING

Cleveland, Ohio, 44106, United States
University Medical Center New Orleans
RECRUITING

New Orleans, Louisiana, 70112, United States
University of California San Diego Moores Cancer Center
RECRUITING

La Jolla, California, 92037, United States
University of Cincinnati Medical Center
RECRUITING

Cincinnati, Ohio, 45219, United States
University of Colorado Hospital - Anshutz Cancer Pavilion
RECRUITING

Aurora, Colorado, 80045, United States
University of Kansas Cancer Center
RECRUITING

Kansas City, Missouri, 64116, United States
University of Kansas Cancer Center Lee's Summit
RECRUITING

Lee's Summit, Missouri, 64064, United States
University of Kansas Cancer Center North
RECRUITING

Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center Overland Park
RECRUITING

Overland Park, Kansas, 66210, United States
University of Kansas Cancer Center Westwood
RECRUITING

Westwood, Kansas, 66205, United States
University of Kansas Clinical Research Center
RECRUITING

Westwood, Kansas, 66205, United States
University of Kansas Hospital
RECRUITING

Kansas City, Kansas, 66160, United States
University of Kansas Indian Creek Breast Surgery
RECRUITING

Overland Park, Kansas, 66211, United States
University of Kansas Medical Center MOB
RECRUITING

Kansas City, Kansas, 66160, United States
University of Kentucky Medical Center
RECRUITING

Lexington, Kentucky, 40536, United States
University of Miami Hospital and Clinics
RECRUITING

Miami, Florida, 33136, United States
University of Miami Hospital and Clinics - Deerfield Beach
RECRUITING

Deerfield Beach, Florida, 33442, United States
University of New Mexico Comprehensive Cancer Center
RECRUITING

Albuquerque, New Mexico, 87102, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37232, United States
Virginia Oncology Associates
RECRUITING

Norfolk, Virginia, 23502, United States
Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63110, United States
West Chester Hospital
RECRUITING

West Chester, Ohio, 45069, United States
West Penn Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15224, United States
Wexford Hospital
RECRUITING

Wexford, Pennsylvania, 15090, United States
Yale University School of Medicine
RECRUITING

New Haven, Connecticut, 06520, United States

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