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

April 15, 2026 updated by: GOG Foundation

GOG-3068: A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin Versus no HIPEC at the Time of Optimal Interval Cytoreductive Surgery Followed by Niraparib Maintenance in Patients With Homologous Recombinant Deficient (HRD +) Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Heated Ovarian Treatment Trial)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
        • Principal Investigator:
          • Thanh Dellinger, MD
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California San Diego Moores Cancer Center
        • Principal Investigator:
          • Michael McHale, MD
        • Contact:
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Memorial Hospital Presbyterian
        • Principal Investigator:
          • Alberto Mendivil, MD
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Women's Cancer Center
        • Principal Investigator:
          • Amer Karam, MD
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford Hospital
        • Principal Investigator:
          • Amer Karam, MD
      • Palo Alto, California, United States, 94034
        • Recruiting
        • Stanford Ambulatory Surgery Center Lane Operating Room
        • Principal Investigator:
          • Amer Karam, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital - Anshutz Cancer Pavilion
        • Principal Investigator:
          • Lindsay J Wheeler Brubaker, MD
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
        • Principal Investigator:
          • Amy Brown, MD
        • Contact:
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University School Of Medicine
        • Contact:
        • Principal Investigator:
          • Elena Ratner, MD
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Smilow Cancer Hospital at Yale- New Haven
        • Contact:
          • Lisa Baker
        • Principal Investigator:
          • Vaagn Andikyan, MD
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Abdulrahman K Sinno, MD
      • Deerfield Beach, Florida, United States, 33442
        • Recruiting
        • University of Miami Hospital and Clinics - Deerfield Beach
        • Principal Investigator:
          • Abdulrahman Sinno, MD
        • Contact:
        • Contact:
      • Miami, Florida, United States, 33176
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital and Clinics
        • Principal Investigator:
          • Abdulrahman Sinno, MD
        • Contact:
        • Contact:
      • Plantation, Florida, United States, 33324
        • Recruiting
        • Sylvester Comprehensive Cancer Center - Plantation
        • Principal Investigator:
          • Abdulrahman Sinno, MD
        • Contact:
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Hospital
        • Principal Investigator:
          • Andrea Jewell, MD
        • Contact:
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center MOB
        • Principal Investigator:
          • Andrea Jewell, MD
        • Contact:
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • University of Kansas Cancer Center Overland Park
        • Principal Investigator:
          • Andrea Jewell, MD
        • Contact:
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • University of Kansas Indian Creek Breast Surgery
        • Principal Investigator:
          • Andrea Jewell, MD
        • Contact:
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Cancer Center Westwood
        • Principal Investigator:
          • Andrea Jewell, MD
        • Contact:
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Clinical Research Center
        • Principal Investigator:
          • Andrea Jewell, MD
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40536
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Principal Investigator:
          • Amelia Jernigan, MD
        • Contact:
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • LSU Health New Orleans
        • Contact:
        • Principal Investigator:
          • Amelia Jernigan, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Carrie Langstraat, MD
    • Missouri
      • Kansas City, Missouri, United States, 64116
        • Recruiting
        • University of Kansas Cancer Center
        • Principal Investigator:
          • Andrea Jewell, MD
        • Contact:
      • Kansas City, Missouri, United States, 64154
        • Recruiting
        • University of Kansas Cancer Center North
        • Principal Investigator:
          • Andrea Jewell, MD
        • Contact:
      • Lee's Summit, Missouri, United States, 64064
        • Recruiting
        • University of Kansas Cancer Center Lee's Summit
        • Principal Investigator:
          • Andrea Jewell, MD
        • Contact:
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Premal Thaker, MD
        • Contact:
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Recruiting
        • Holy Name Medical Center
        • Contact:
        • Principal Investigator:
          • Sharyn Lewin
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • University of New Mexico Comprehensive Cancer Center
        • Principal Investigator:
          • Carolyn Muller, MD
        • Contact:
    • New York
      • New York, New York, United States, 10022
        • Recruiting
        • Memorial Sloan-Kettering Cancer Center
        • Contact:
        • Principal Investigator:
          • Dennis Chi, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Center
        • Contact:
        • Principal Investigator:
          • Jennifer L McNally, MD
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Duke Women's Cancer Care Raleigh
        • Principal Investigator:
          • Jennifer L McNally, MD
    • Ohio
      • Chardon, Ohio, United States, 44024
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
        • Principal Investigator:
          • Caroline Billingsley, MD
        • Contact:
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • TriHealth Cancer Institute - Good Samaritan Hospital
        • Principal Investigator:
          • Robert Neff, MD
        • Contact:
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • TriHealth Cancer Institute- Thomas Comprehensive Care Center
        • Principal Investigator:
          • Robert Neff, MD
        • Contact:
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Sarah Lynam, MD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Robert Debernardo Jr., MD
      • Mentor, Ohio, United States, 44060
      • Orange, Ohio, United States, 44122
        • Recruiting
        • UH Minoff Health Center at Chagrin Highlands
        • Contact:
        • Principal Investigator:
          • Sarah Lynam, MD
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • West Chester Hospital
        • Principal Investigator:
          • Caroline Billingsley, MD
        • Contact:
      • Westlake, Ohio, United States, 44145
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Recruiting
        • Jefferson Abington Hospital
        • Principal Investigator:
          • Lea Moukarzel, MD
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Recruiting
        • Jefferson Hospital
        • Principal Investigator:
          • John Nakayama, MD
        • Contact:
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • Forbes Hospital
        • Principal Investigator:
          • John Nakayama, MD
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • West Penn Hospital
        • Principal Investigator:
          • John Nakayama, MD
        • Contact:
      • Wexford, Pennsylvania, United States, 15090
        • Recruiting
        • Wexford Hospital
        • Principal Investigator:
          • John Nakayama, MD
        • Contact:
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Asplundh Cancer Pavilion
        • Principal Investigator:
          • Lea Moukarzel, MD
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Medical Center/Mainline Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Holtz, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina (Hollings Cancer Center)
        • Principal Investigator:
          • Brian Orr, MD
        • Contact:
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • Marta Crispens, MD
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • Texas Oncology - Central South
        • Principal Investigator:
          • Helen Eshed, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine Medical Center
        • Contact:
        • Principal Investigator:
          • Anthony Costales, MD
      • Houston, Texas, United States, 77054
        • Recruiting
        • O'Quinn Medical Tower at McNair Campus
        • Contact:
        • Principal Investigator:
          • Anthony Costales, MD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute
        • Principal Investigator:
          • Leslie Randall, MD
        • Contact:
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Oncology Associates
        • Contact:
        • Principal Investigator:
          • Danielle Chau, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Memorial Lutheran Hospital & Medical College of Wisconsin
        • Principal Investigator:
          • Denise Uyar, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIPEC
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cisplatin 100 mg/m2 IP over 90 minutes at 42 degrees C
Drug: Cisplatin
Cisplatin 100mg/m2 IP over 90 minutes at 42 degrees Celcius
Other Names:
  • Platinol AQ
Active Comparator: No HIPEC
No treatment
Other: No treatment
No treatment with Cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: From enrollment until time of disease progression or death, whichever occurs first, or date of last contact if neither progression of death has occurred, assessed up to 8 years
Progression free survival in patients who receive a single treatment of intraoperative HIPEC with cisplatin vs. those who do not receive intraoperative HIPEC with cisplatin.
From enrollment until time of disease progression or death, whichever occurs first, or date of last contact if neither progression of death has occurred, assessed up to 8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From enrollment to the time of death or date of last contact, assessed up to 8 years

Overall survival stratified by:

  1. Stage at diagnosis (stage III vs. stage IV)
  2. Germline or somatic mutation (yes vs. no)
  3. Physician choice bevacizumab (yes vs. no)
  4. Residual disease (no gross/visible residual disease vs. gross/visible residual disease less than or equal to 1 cm in longest diameter
From enrollment to the time of death or date of last contact, assessed up to 8 years
Frequency and severity of adverse events
Time Frame: Every 28 days up to 3 years
The frequency and severity of adverse events as defined by CTCAE version 5.0
Every 28 days up to 3 years
Progression Free Survival
Time Frame: From the time of randomization until the date of first documented disease progression or death from any cause, whichever came first, assessed up to 8 years

Progression Free Survival stratified by:

  1. Stage at diagnosis (stage III vs. stage IV)
  2. Germline or somatic mutation (yes vs. no)
  3. Physician choice bevacizumab (yes vs. no)
  4. Residual disease (no gross/visible residual disease vs. gross/visible residual disease less than or equal to 1 cm in longest diameter
From the time of randomization until the date of first documented disease progression or death from any cause, whichever came first, assessed up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GOG Foundation

Collaborators

GlaxoSmithKline

Investigators

  • Study Chair: Leslie Randall, MD, GOG Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2024

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2034

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

December 12, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-3068
  • 217908 (Other Identifier: GSK)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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