A Phase II Randomized Study Comparing PARP Inhibitor Maintenance Regimens in High-Risk Advanced Ovarian Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1041260072

Enrollment

Registered

2026-06-24

Start date

2026-06-24

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer

Interventions

Patients with advanced ovarian cancer who have undergone neoadjuvant chemotherapy (NAC) followed by interval debulking surgery (IDS), who achieved optimal debulking with a maximum residual tumor diame

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Patients meeting all of the following criteria will be eligible for enrollment: written informed consent has been obtained; patients have advanced ovarian cancer and have undergone interval debulking surgery (IDS) following neoadjuvant chemotherapy (NAC); optimal surgery has been achieved at IDS, defined as a maximum residual tumor diameter of 1 cm or less; homologous recombination deficiency (HRD)-positive status has been confirmed; no age restriction applies; Eastern Cooperative Oncology Group (ECOG) Performance Status is 0 or 1; and adequate hematologic and major organ function is present to safely initiate maintenance therapy following completion of neoadjuvant chemotherapy. Specifically, laboratory criteria include an absolute neutrophil count of 1,500/mm^3 or greater, a platelet count of 100,000/mm^3 or greater, hemoglobin of 9.0 g/dL or greater, AST and ALT no greater than 2.5 times the upper limit of normal (ULN), total bilirubin no greater than 1.5 times the ULN, and serum creatinine no greater than 1.5 times the ULN or estimated glomerular filtration rate (eGFR) of 50 mL/min or greater.

Exclusion criteria

Exclusion criteria: Patients will be excluded if they have uncontrolled thromboembolic disease, uncontrolled hypertension, or an active synchronous malignancy.

Design outcomes

Primary

Measure	Time frame
Difference in the change from baseline to Week 48 in the Global Health Status/Quality of Life (GHS/QoL) score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).	—

Contacts

Public ContactSatoshi Tamauchi

Department of Obstetrics and Gynecology, Nagoya University Graduate School of Medicine

tama-sato@med.nagoya-u.ac.jp+81-52-744-2261

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026