Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix
Status:
Recruiting
Trial end date:
2026-03-02
Target enrollment:
Participant gender:
Summary
The most effective strategy for managing distantly metastatic invasive carcinomas of the
cervix is not defined. Based on the success of niraparib in breast and ovarian cancer trials
and the concern for toxicities and comorbidities limiting the compliance of concurrent
cisplatin for cervical cancer, this study is a phase I/II study of women diagnosed with
distantly metastatic (Stage IV) disease to determine the maximum tolerated dose and to
evaluate the safety, tolerability and preliminary efficacy of niraparib, an orally available
small molecule PARP inhibitor when administered concurrently with definitive regional
radiotherapy for treatment of cervical cancer. Women enrolled in this study will receive 3-6
cycles of induction-style carboplatin and paclitaxel followed by definitive doses of pelvic
radiotherapy along with the oral niraparib given at the same time.