Clinical trialNCT05659381RecruitingPhase 3Interventional

Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer

SponsorGOG FoundationEnrollment220Stage III Fallopian Tube CancerStage III Ovarian CancerStage III Primary Peritoneal CancerStage IV Fallopian Tube CancerStage IV Ovarian CancerStage IV Primary Peritoneal Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Leslie Randall, MD
GOG Foundation
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

59 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

City of Hope
Duarte, California, United States
Thanh Dellinger, MD
Recruiting
University of California San Diego Moores Cancer Center
La Jolla, California, United States
Michael McHale, MD
Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Alberto Mendivil, MD
Recruiting
Stanford Ambulatory Surgery Center Lane Operating Room
Palo Alto, California, United States
Amer Karam, MD
Recruiting
Stanford Hospital
Palo Alto, California, United States
Amer Karam, MD
Recruiting
Stanford Women'S Cancer Center
Palo Alto, California, United States
Amer Karam, MD
Recruiting
University of Colorado Hospital - Anshutz Cancer Pavilion
Aurora, Colorado, United States
Lindsay J Wheeler Brubaker, MD
Recruiting
Hartford Hospital
Hartford, Connecticut, United States
Amy Brown, MD
Recruiting
Smilow Cancer Hospital at Yale- New Haven
New Haven, Connecticut, United States
Vaagn Andikyan, MD
Recruiting
Yale University School of Medicine
New Haven, Connecticut, United States
Elena Ratner, MD
Recruiting
Sylvester Comprehensive Cancer Center - the Lennar Foundation Medical Center
Coral Gables, Florida, United States
Abdulrahman K Sinno, MD
Recruiting
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida, United States
Abdulrahman Sinno, MD
Recruiting
Miami Cancer Institute
Miami, Florida, United States
John Diaz, MD
Recruiting
University of Miami Hospital and Clinics
Miami, Florida, United States
Abdulrahman Sinno, MD
Recruiting
Sylvester Comprehensive Cancer Center - Plantation
Plantation, Florida, United States
Abdulrahman Sinno, MD
Recruiting
University of Kansas Hospital
Kansas City, Kansas, United States
Andrea Jewell, MD
Recruiting
University of Kansas Medical Center Mob
Kansas City, Kansas, United States
Andrea Jewell, MD
Recruiting
University of Kansas Cancer Center Overland Park
Overland Park, Kansas, United States
Andrea Jewell, MD
Recruiting
University of Kansas Indian Creek Breast Surgery
Overland Park, Kansas, United States
Andrea Jewell, MD
Recruiting
University of Kansas Cancer Center Westwood
Westwood, Kansas, United States
Andrea Jewell, MD
Recruiting
University of Kansas Clinical Research Center
Westwood, Kansas, United States
Andrea Jewell, MD
Recruiting
University of Kentucky Medical Center
Lexington, Kentucky, United States
Charles Dietrich, MD
Recruiting
Lsu Health New Orleans
New Orleans, Louisiana, United States
Amelia Jernigan, MD
Recruiting
University Medical Center New Orleans
New Orleans, Louisiana, United States
Amelia Jernigan, MD
Recruiting
Mayo Clinic
Rochester, Minnesota, United States
Carrie Langstraat, MD
Recruiting
University of Kansas Cancer Center
Kansas City, Missouri, United States
Andrea Jewell, MD
Recruiting
University of Kansas Cancer Center North
Kansas City, Missouri, United States
Andrea Jewell, MD
Recruiting
University of Kansas Cancer Center Lee'S Summit
Lee's Summit, Missouri, United States
Andrea Jewell, MD
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Premal Thaker, MD
Recruiting
Holy Name Medical Center
Teaneck, New Jersey, United States
Sharyn Lewin
Recruiting
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Carolyn Muller, MD
Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Dennis Chi, MD
Recruiting
Duke Cancer Center
Durham, North Carolina, United States
Jennifer L McNally, MD
Recruiting
Duke Women'S Cancer Care Raleigh
Raleigh, North Carolina, United States
Jennifer L McNally, MD
Recruiting
Uh Geauga Medical Center
Chardon, Ohio, United States
Sarah Lynam, MD
Recruiting
Trihealth Cancer Institute - Good Samaritan Hospital
Cincinnati, Ohio, United States
Robert Neff, MD
Recruiting
Trihealth Cancer Institute- Thomas Comprehensive Care Center
Cincinnati, Ohio, United States
Robert Neff, MD
Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Caroline Billingsley, MD
Recruiting
Cleveland Clinic
Cleveland, Ohio, United States
Robert Debernardo Jr., MD
Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Sarah Lynam, MD
Recruiting

19 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cisplatin →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 8 Mar 2024
Primary completion: 1 Aug 2029
Completion: 1 Aug 2034
Last update posted: 16 Apr 2026
Registered enrollment: 220
Registry id: NCT05659381

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.