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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Cisplatin 100mg/m2 IP over 90 minutes at 42 degrees Celcius
No treatment with Cisplatin
City of Hope
Duarte, California, United States
RECRUITINGUniversity of California San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGHoag Memorial Hospital Presbyterian
Newport Beach, California, United States
RECRUITINGStanford Ambulatory Surgery Center Lane Operating Room
Palo Alto, California, United States
Progression-free survival
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.
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
Overall Survival
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
Time frame: From enrollment to the time of death or date of last contact, assessed up to 8 years
Frequency and severity of adverse events
The frequency and severity of adverse events as defined by CTCAE version 5.0
Time frame: Every 28 days up to 3 years
Progression Free Survival
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
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
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Stanford Women's Cancer Center
Palo Alto, California, United States
RECRUITINGStanford Hospital
Palo Alto, California, United States
RECRUITINGUniversity of Colorado Hospital - Anshutz Cancer Pavilion
Aurora, Colorado, United States
RECRUITINGSmilow Cancer Hospital at Yale- New Haven
New Haven, Connecticut, United States
RECRUITINGYale University School of Medicine
New Haven, Connecticut, United States
RECRUITINGSylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
Coral Gables, Florida, United States
RECRUITING...and 48 more locations