Actively Recruiting
GOG-3068: Randomized Trial of Heated Intraperitoneal Chemotherapy With Cisplatin Versus No HIPEC During Interval Cytoreductive Surgery Followed by Niraparib Maintenance in HRD+ Stage III-IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
Led by GOG Foundation · Updated on 2026-04-16
220
Participants Needed
59
Research Sites
260 weeks
Total Duration
On this page
Sponsors
G
GOG Foundation
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the use of heated intraperitoneal chemotherapy (HIPEC) with cisplatin followed by niraparib maintenance compared to surgery without HIPEC in patients with newly diagnosed advanced ovarian, primary peritoneal, or fallopian tube cancer that is homologous recombinant deficient (HRD+). The study focuses on patients with stage III or IV disease undergoing neoadjuvant chemotherapy and interval cytoreductive surgery (iCRS). It is a phase III randomized trial sponsored by the GOG Foundation to assess progression-free survival and overall survival among these patients. Patients first receive neoadjuvant platinum-based chemotherapy with or without bevacizumab every 21 days for 3 to 4 cycles. After chemotherapy, patients undergo interval cytoreductive surgery aiming for no visible disease or minimal residual disease (≤1.0 cm). At surgery, participants are randomized to receive either HIPEC with cisplatin (100 mg/m2 intraperitoneally over 90 minutes at 42°C) or no HIPEC. Following recovery, all patients receive additional platinum-based chemotherapy cycles to complete up to six total cycles, followed by maintenance treatment with niraparib, with or without bevacizumab, until disease progression or for up to 36 months if no disease is evident. Throughout the study, participants will be monitored for disease progression, survival, and adverse events for up to 8 years. Assessments include imaging scans and clinical evaluations to measure progression-free survival and overall survival. Safety is monitored regularly with evaluations every 28 days for up to 3 years. Participants' blood counts, organ function, and neurological status are assessed to ensure treatment tolerance. The study includes long-term follow-up to evaluate outcomes and safety over an extended period.
CONDITIONS
Brief Title
Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have high grade serous or endometrioid epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, stage III or IV confirmed by imaging.
- Planned for 3-4 cycles of platinum-based neoadjuvant chemotherapy with or without bevacizumab.
- Candidates for interval cytoreductive surgery (iCRS) with no or minimal residual disease (≤1.0 cm).
- Tumors must be HRD/LOH positive or have BRCA or similar mutations; HRD testing required if no BRCA mutation.
- Adequate bone marrow, renal, hepatic, and neurologic function.
- ECOG performance status 0 or 1.
- Age over 18 years.
- Life expectancy greater than 3 months.
- Negative pregnancy test and effective contraception for those of childbearing potential.
- Controlled blood pressure and stable corticosteroid use allowed.
- Patients with controlled HIV infection meeting specific criteria.
- Signed informed consent allowing release of personal health information.
You will not qualify if you...
- Low-grade serous, clear cell, mucinous, non-epithelial ovarian cancers or borderline tumors.
- Prior treatment for ovarian cancer other than 3-4 cycles of neoadjuvant chemotherapy.
- HRD/LOH negative tumors.
- Disease progression during neoadjuvant chemotherapy.
- Medical conditions preventing interval cytoreductive surgery.
- Stage IV disease without complete response of extra-abdominal disease or unresectable disease.
- History of myelodysplastic syndrome or acute myeloid leukemia.
- Pregnancy or lactation.
- Severe infection requiring IV antibiotics within 2 weeks.
- Other uncontrolled medical conditions.
- Central nervous system metastases.
- Uncontrolled insulin-dependent diabetes or renal conditions.
- Pre-existing hearing loss from prior platinum chemotherapy.
- Prior reversible encephalopathy syndrome.
- Active liver or biliary disease or severe hepatic impairment.
- Significant gastrointestinal abnormalities affecting absorption.
- Significant cardiovascular disease or recent serious events.
- Increased bleeding risk or recent major surgery.
- Active hepatitis B unless stably controlled.
- Recent investigational therapy or live vaccine administration.
- Recent other invasive cancer within 2 years (with exceptions).
- Recent radiotherapy involving significant bone marrow or recent radiation therapy prior to randomization.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus immediate recovery period
Participants undergo interval cytoreductive surgery with or without heated intraperitoneal chemotherapy (HIPEC) using Cisplatin.
1 surgery visit and immediate post-operative care
Duration - Up to 3 years
Participants receive maintenance treatment with Niraparib following surgery.
Visits every 28 days during treatment
Duration - Up to 8 years from enrollment
Participants are monitored for disease progression, survival, and adverse events after treatment ends.
Periodic visits for assessment as scheduled by the study
Trial Site Locations
Total: 59 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
University of California San Diego Moores Cancer Center
La Jolla, California, United States, 92037
Actively Recruiting
3
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
4
Stanford Ambulatory Surgery Center Lane Operating Room
Palo Alto, California, United States, 94034
Actively Recruiting
5
Stanford Women's Cancer Center
Palo Alto, California, United States, 94304
Actively Recruiting
6
Stanford Hospital
Palo Alto, California, United States, 94305
Actively Recruiting
7
University of Colorado Hospital - Anshutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Actively Recruiting
8
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
9
Smilow Cancer Hospital at Yale- New Haven
New Haven, Connecticut, United States, 06511
Actively Recruiting
10
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Actively Recruiting
11
Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
Coral Gables, Florida, United States, 33146
Actively Recruiting
12
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
13
University of Miami Hospital and Clinics
Miami, Florida, United States, 33136
Actively Recruiting
14
Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
15
Sylvester Comprehensive Cancer Center - Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
16
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
Actively Recruiting
17
University of Kansas Medical Center MOB
Kansas City, Kansas, United States, 66160
Actively Recruiting
18
University of Kansas Cancer Center Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
19
University of Kansas Indian Creek Breast Surgery
Overland Park, Kansas, United States, 66211
Actively Recruiting
20
University of Kansas Cancer Center Westwood
Westwood, Kansas, United States, 66205
Actively Recruiting
21
University of Kansas Clinical Research Center
Westwood, Kansas, United States, 66205
Actively Recruiting
22
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
23
LSU Health New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
24
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
25
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
26
University of Kansas Cancer Center
Kansas City, Missouri, United States, 64116
Actively Recruiting
27
University of Kansas Cancer Center North
Kansas City, Missouri, United States, 64154
Actively Recruiting
28
University of Kansas Cancer Center Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
29
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
30
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
Actively Recruiting
31
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
32
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10022
Actively Recruiting
33
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
34
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, United States, 27607
Actively Recruiting
35
UH Geauga Medical Center
Chardon, Ohio, United States, 44024
Actively Recruiting
36
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
37
TriHealth Cancer Institute - Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Actively Recruiting
38
TriHealth Cancer Institute- Thomas Comprehensive Care Center
Cincinnati, Ohio, United States, 45242
Actively Recruiting
39
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
40
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
41
SCC at Lake University
Mentor, Ohio, United States, 44060
Actively Recruiting
42
UH Minoff Health Center at Chagrin Highlands
Orange, Ohio, United States, 44122
Actively Recruiting
43
West Chester Hospital
West Chester, Ohio, United States, 45069
Actively Recruiting
44
St. John Medical Center
Westlake, Ohio, United States, 44145
Actively Recruiting
45
Jefferson Abington Hospital
Abington, Pennsylvania, United States, 19001
Actively Recruiting
46
Jefferson Hospital
Jefferson Hills, Pennsylvania, United States, 15025
Actively Recruiting
47
Forbes Hospital
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
48
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
49
Wexford Hospital
Wexford, Pennsylvania, United States, 15090
Actively Recruiting
50
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States, 19090
Actively Recruiting
51
Lankenau Medical Center/Mainline Medical Center
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
52
Medical University of South Carolina (Hollings Cancer Center)
Charleston, South Carolina, United States, 29425
Actively Recruiting
53
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
54
Texas Oncology - Central South
Austin, Texas, United States, 78758
Actively Recruiting
55
Baylor College of Medicine Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
56
O'Quinn Medical Tower at McNair Campus
Houston, Texas, United States, 77054
Actively Recruiting
57
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
58
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
59
Froedtert Memorial Lutheran Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
S
Sarin Chhab
S
Shanon Matkin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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