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

Recruiting Phase 3 Interventional Study
Stage III Ovarian Cancer Stage IV Ovarian Cancer Stage III Primary Peritoneal Cancer Stage IV Primary Peritoneal Cancer Stage III Fallopian Tube Cancer Stage IV Fallopian Tube Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
GOG Foundation · Research network
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About This 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 su…
Trial Locations
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Eligibility Criteria
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 …
Contacts

Sarin Chhab

215-854-0770

schhab@gog.org

CONTACT

Shanon Matkin

801-661-1584

smatkin@gog.org

CONTACT