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A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy

ConditionsOvarian CancerFallopian Tube CancerPrimary Peritoneal CarcinomaClear Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNorth Eastern German Society of Gynaecological Oncology

About this trial

Multicenter, randomized, open label study including patients with advanced HRDpositive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary with no residual tumor mass following primary tumor debulking to determine recurrence free survival in patients treated with 3 cycles carboplatin + paclitaxel and maintenance therapy with niraparib vs. 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent and obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.

Female patient, age ≥ 18 years.

FIGO Stage III-IV high-grade ovarian cancer (all histological types, except mucinous histology)

Complete primary debulked patients (without any macroscopic residuals), confirmed by CT-Scan postoperatively.

Disqualifiers

Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e., germ cell tumors) and Ovarian tumors of low malignant potential (e.g., borderline tumors), or mucinous carcinoma of the ovary.

Low-grade ovarian, fallopian tube or peritoneal cancer.

Has known hypersensitivity to any of the study drugs or any of the excipients of any of the study drugs.

Has known hypersensitivity to platin-containing compounds other than carboplatin.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3 cycles chemotherapy instead of 6 cycles chemotherapy

    Drug

    We hypothesise that recurrence free survival in patients receiving 3 cycles of chemotherapy followed by maintenance with niraparib is not inferior to 6 cycles of chemotherapy followed by niraparib in advanced HRDpositive high-grade ovarian cancer patients with no residual tumor mass following primary tumor debulking.

  • 6 cycles chemotherapy

    Drug

    Standard chemotherapy as comparator

Treatment groups

640 Participants
are divided into 2 treatment groups
Group A: Arm A (3 cycles of chemotherapy + maintenance therapy with niraparib)Experimental treatment 1 intervention
Group B: Arm B (6 cycles of chemotherapy + maintenance therapy with niraparib)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

RFS

Recurrence free survival, defined as time from treatment randomization to the earliest date of assessment of first relapse or death by any cause

Time frame
8 years

Secondary outcomes

1

Overall survival (OS)

time to event and rate at 3 and 5 years

Time frame
8 years
2

TFST

Time to first subsequent treatment

Time frame
8 years
3

TWIST (Time Without Symptoms of disease progression or Toxicity of treatment)

at baseline, 3, 6, and 12 months

Time frame
8 years
4

PFS2

Time from randomization until the date of second objective disease progression or death by any cause

Time frame
8 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

North Eastern German Society of Gynaecological Oncology

Lead sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborator

Source ClinicalTrials.gov
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