Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer
Start Date
3/8/2024
Completion Date
8/1/2034
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Cisplatin
No treatment
Conditions
Locations
City of Hope
Duarte, California 91010
United States
University of California San Diego Moores Cancer Center
La Jolla, California 92037
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United States
Stanford Ambulatory Surgery Center Lane Operating Room
Palo Alto, California 94034
United States
Stanford Women's Cancer Center
Palo Alto, California 94304
United States
Stanford Hospital
Palo Alto, California 94305
United States
University of Colorado Hospital - Anshutz Cancer Pavilion
Aurora, Colorado 80045
United States
Hartford Hospital
Hartford, Connecticut 06102
United States
Smilow Cancer Hospital at Yale- New Haven
New Haven, Connecticut 06511
United States
Yale University School of Medicine
New Haven, Connecticut 06520
United States
Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
Coral Gables, Florida 33146
United States
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida 33442
United States
University of Miami Hospital and Clinics
Miami, Florida 33136
United States
Miami Cancer Institute
Miami, Florida 33176
United States
Sylvester Comprehensive Cancer Center - Plantation
Plantation, Florida 33324
United States
University of Kansas Hospital
Kansas City, Kansas 66160
United States
University of Kansas Medical Center MOB
Kansas City, Kansas 66160
United States
University of Kansas Cancer Center Overland Park
Overland Park, Kansas 66210
United States
University of Kansas Indian Creek Breast Surgery
Overland Park, Kansas 66211
United States
University of Kansas Cancer Center Westwood
Westwood, Kansas 66205
United States
University of Kansas Clinical Research Center
Westwood, Kansas 66205
United States
University of Kentucky Medical Center
Lexington, Kentucky 40536
United States
LSU Health New Orleans
New Orleans, Louisiana 70112
United States
University Medical Center New Orleans
New Orleans, Louisiana 70112
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
University of Kansas Cancer Center
Kansas City, Missouri 64116
United States
University of Kansas Cancer Center North
Kansas City, Missouri 64154
United States
University of Kansas Cancer Center Lee's Summit
Lee's Summit, Missouri 64064
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Holy Name Medical Center
Teaneck, New Jersey 07666
United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico 87102
United States
Memorial Sloan-Kettering Cancer Center
New York, New York 10022
United States
Duke Cancer Center
Durham, North Carolina 27710
United States
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina 27607
United States
UH Geauga Medical Center
Chardon, Ohio 44024
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United States
TriHealth Cancer Institute - Good Samaritan Hospital
Cincinnati, Ohio 45220
United States
TriHealth Cancer Institute- Thomas Comprehensive Care Center
Cincinnati, Ohio 45242
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
SCC at Lake University
Mentor, Ohio 44060
United States
UH Minoff Health Center at Chagrin Highlands
Orange, Ohio 44122
United States
West Chester Hospital
West Chester, Ohio 45069
United States
St. John Medical Center
Westlake, Ohio 44145
United States
Jefferson Abington Hospital
Abington, Pennsylvania 19001
United States
Jefferson Hospital
Jefferson Hills, Pennsylvania 15025
United States
Forbes Hospital
Monroeville, Pennsylvania 15146
United States
West Penn Hospital
Pittsburgh, Pennsylvania 15224
United States
Wexford Hospital
Wexford, Pennsylvania 15090
United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
United States
Lankenau Medical Center/Mainline Medical Center
Wynnewood, Pennsylvania 19096
United States
Medical University of South Carolina (Hollings Cancer Center)
Charleston, South Carolina 29425
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Texas Oncology - Central South
Austin, Texas 78758
United States
Baylor College of Medicine Medical Center
Houston, Texas 77030
United States
O'Quinn Medical Tower at McNair Campus
Houston, Texas 77054
United States
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United States
Virginia Oncology Associates
Norfolk, Virginia 23502
United States
Froedtert Memorial Lutheran Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States