Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer

Sponsor
Tongji Hospital
Study ID
NCT04507841
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Neoadjuvant niraparib monotherapy with an individualized starting dose of 200mg/day or 300mg/day based on body weight or platelet count. The 28-day treatment cycle consists of 21 days of medication followed by a 7-day break. Two cycles of neoadjuvant niraparib monotherapy were used, and the investigator may choose to have an additional cycle based on the patient's condition.

Study Details

This is a prospective, interventional, single-arm, open-label, phase II study to evaluate the safety and efficacy of niraparib monotherapy as neoadjuvant therapy in patients with advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer ((FIGO stage III or IV), who had low likelihood of achieving R0 cytoreduction by imaging assessment or laparoscopic evaluation, or cannot tolerate PDS by poor conditions.

Key Dates

Start date
Jan 8, 2021
Status verified
Dec 2024
Primary completion
Sep 25, 2023
Completion
Dec 31, 2026

Study Design

Enrollment
67 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib group
    Niraparib was used in patients with newly diagnosed ovarian cancer before any treatment with an individualized starting dose of 200mg/day or 300mg/day based on body weight or platelet count.

Primary Outcome Measure

R0 resection rate [ Time Frame: 3-month ]

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