Actively Recruiting
Led by North Eastern German Society of Gynaecological Oncology · Updated on 2026-02-12
640
Participants Needed
47
Research Sites
N/A
Total Duration
N
North Eastern German Society of Gynaecological Oncology
Lead Sponsor
I
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborating Sponsor
Researchers are evaluating treatments for advanced HRD-positive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and clear cell carcinoma of the ovary. The study focuses on patients with no visible tumor remaining after primary tumor debulking surgery. It aims to compare the time patients remain free from cancer recurrence when treated with different lengths of chemotherapy followed by maintenance therapy with niraparib. Participants are randomly assigned to one of two groups. One group receives 3 cycles of carboplatin plus paclitaxel chemotherapy followed by niraparib maintenance therapy, while the other group receives 6 cycles of the same chemotherapy followed by niraparib maintenance. Niraparib is taken orally daily, starting at a dose of either 200 mg or 300 mg. Treatment continues until disease progression, unacceptable side effects, or other stopping reasons. Tumor assessments using CT or MRI scans and blood tests for the tumor marker CA-125 are performed regularly to monitor disease status. During chemotherapy, clinical visits including blood tests and toxicity monitoring occur every 3 weeks, and pregnancy tests are done every 4 weeks for women of childbearing potential. During niraparib maintenance, visits and safety monitoring happen every 4 weeks for the first 11 months, then every 12 weeks afterward. Physical exams take place every 12 weeks. Safety is closely monitored through adverse event reporting. The study plans to enroll 640 patients across about 60 sites in Europe, with follow-up lasting up to 8 years to assess recurrence-free survival and other outcomes.
CONDITIONS
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
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 to 6 months depending on chemotherapy cycles plus maintenance therapy until progression or discontinuation
Participants receive either 3 or 6 cycles of chemotherapy followed by maintenance therapy with niraparib until disease progression or other stopping criteria. Clinical visits occur regularly for monitoring blood counts, toxicity, and pregnancy tests.
Clinical visits at least every 3 weeks during chemotherapy; every 4 weeks during first 11 months of maintenance; then every 12 weeks thereafter
Duration - Up to 8 years
Participants undergo tumor assessments and monitoring of tumor markers and safety for up to 8 years after treatment to evaluate recurrence-free survival and overall health.
Tumor assessments every 9-12 weeks initially, then every 6 months; CA-125 marker assessed every 12 weeks; physical exams every 12 weeks
Total: 47 locations
1
Universitätsklinik Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
2
Cliniques Universitaires St. Luc
Brussels, Belgium
Active, Not Recruiting
3
UZ Gent
Ghent, Belgium
Not Yet Recruiting
4
Jessa ziekenhuis
Hasselt, Belgium
Not Yet Recruiting
5
UZ Leuven
Leuven, Belgium
Active, Not Recruiting
6
University Hospital Ostrava
Ostrava, Czechia
Active, Not Recruiting
7
General University Hospital in Prague
Prague, Czechia
Actively Recruiting
8
University Hospital Bulovka
Prague, Czechia
Active, Not Recruiting
9
Universitätsklinikum Aachen
Aachen, Germany, 52074
Actively Recruiting
10
Klinikum Mittelbaden Baden-Baden Bühl
Baden-Baden, Germany
Not Yet Recruiting
11
DRK-Kliniken Berlin-Köpenick
Berlin, Germany, 12559
Actively Recruiting
12
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, Germany, 13353
Actively Recruiting
13
ZAHO Bonn Onkologische Praxis
Bonn, Germany, 53115
Active, Not Recruiting
14
Uniklinikum Bonn
Bonn, Germany
Active, Not Recruiting
15
Klinikum Lippe
Detmold, Germany
Actively Recruiting
16
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Active, Not Recruiting
17
Florence-Nightingale-Krankenhaus Düsseldorf-Kaiserswerth
Düsseldorf, Germany
Active, Not Recruiting
18
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Active, Not Recruiting
19
Universitätsklinik Göttingen
Göttingen, Germany
Active, Not Recruiting
20
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Active, Not Recruiting
21
SLK-Kliniken Heilbronn
Heilbronn, Germany
Not Yet Recruiting
22
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Germany
Active, Not Recruiting
23
Universitätsklinikum Leipzig
Leipzig, Germany
Active, Not Recruiting
24
Universitätsklinik der Johannes-Gutenberg Universität Mainz
Mainz, Germany, 55131
Active, Not Recruiting
25
Diakonie Klinikum Schwäbisch Hall
Schwäbisch Hall, Germany
Actively Recruiting
26
Christliches Klinikum Unna Mitte
Unna, Germany, 59423
Active, Not Recruiting
27
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, Germany, 65199
Actively Recruiting
28
Policlinico St. Orsola Malpighi
Bologna, Italy
Active, Not Recruiting
29
ASST Spedali Civili di Brescia
Brescia, Italy
Active, Not Recruiting
30
ASST Lecco - Ospedale A. Manzoni
Lecco, Italy
Not Yet Recruiting
31
IRCCS Istituto nazionale dei Tumori
Milan, Italy
Not Yet Recruiting
32
AOU Cagliari
Monserrato, Italy
Not Yet Recruiting
33
Istituto Oncologico Veneto (IOV)
Padova, Italy
Active, Not Recruiting
34
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy
Active, Not Recruiting
35
Azienda USL IRCCS Di Reggio Emilia
Reggio Emilia, Italy
Active, Not Recruiting
36
AO Ordine Mauriziano
Torino, Italy
Active, Not Recruiting
37
AOU Città della Salute e della Scienza di Torino - Ospedale Sant'Anna
Torino, Italy
Not Yet Recruiting
38
Hospital General Universitario Dr. Balmis
Alicante, Spain
Active, Not Recruiting
39
Hospital Virgen de las Nieves
Granada, Spain
Active, Not Recruiting
40
Hospital Universitario Lucus Augusti
Lugo, Spain
Active, Not Recruiting
41
CIOCC Clara Campal
Madrid, Spain
Active, Not Recruiting
42
H. Althaia Manresa
Manresa, Spain
Active, Not Recruiting
43
H.U. Virgen de la Macarena
Seville, Spain
Active, Not Recruiting
44
Hospital Universitario Virgen del Rocío
Seville, Spain
Active, Not Recruiting
45
Hospital Universitario Sant Joan de Reus
Tarragona, Spain
Active, Not Recruiting
46
Hospital General Universitario de Valencia
Valencia, Spain
Actively Recruiting
47
Hospital La Fe
Valencia, Spain
Active, Not Recruiting
J
Jessica Nguyen
J
Jasmin Yamamoto
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Jalid Sehouli, Klaus Pietzner, Dario Zocholl...
https://pubmed.ncbi.nlm.nih.gov/42140839