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

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 diamete

Trial Details

NCT ID
NCT05659381
Phase
PHASE3
Sponsor
GOG Foundation
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • Cisplatin
  • No treatment
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Palo Alto, California, United States|37.44188,-122.14302
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Hartford, Connecticut, United States|41.76371,-72.68509
  • Coral Gables, Florida, United States|25.72149,-80.26838

Key Eligibility Criteria

  • Patients must have a pathologic diagnosis of high grade serous or endometroid epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, …
  • Patients with stage IV disease must have complete response of extra-abdominal disease on preoperative imaging (e.g. pleural effusion, mediastinal, …
  • Patients must have HRD/LOH positive tumors. Patients with germline or somatic BRCA or other similar mutations (RAD51C, RAD51D, BRIP1, BARD) are not…
  • Patients must have R0 (no gross/visible residual disease) or R1 (gross/visible residual disease ≤ 1.0 cm in the longest diameter) following iCRS an…

For full eligibility, visit ClinicalTrials.gov.

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