Actively Recruiting
Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer
Led by ARCAGY/ GINECO GROUP · Updated on 2026-04-13
390
Participants Needed
88
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy +/-bevacizumab.
CONDITIONS
Official Title
Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Newly diagnosed with high-grade serous, high-grade endometrioid (grade 2 or 3), or other specified epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Advanced cancer stage IIIA to IIIC as per 2018 FIGO classification
- Completed frontline complete cytoreductive surgery with no visible disease
- ECOG performance status 0 or 1
- Received at least one cycle of carboplatin (AUC 5-6) plus paclitaxel (175 mg/m2)
- Started first chemotherapy cycle within 6 weeks after surgery
- No evidence of disease on thorax-abdomen-pelvis CT scan between surgery and first chemotherapy cycle
- Eligible for first-line platinum-taxane chemotherapy
- Eligible for bevacizumab treatment starting at second chemotherapy cycle and continuing for 15 months
- Normal organ and bone marrow function before first chemotherapy cycle, including specified blood counts and liver/kidney function
- Urine dipstick proteinuria less than 2+ or 24-hour proteinuria less than 1 g if 2+ or higher
- Controlled blood pressure (systolic ≤ 140 mmHg and/or diastolic ≤ 90 mmHg)
- Available tumor sample for local BRCA testing and optional HRD testing
- Affiliated with or beneficiary of social security where applicable
- Signed informed consent and able to comply with treatment and follow-up
You will not qualify if you...
- Clear cell adenocarcinoma, carcinosarcoma, non-epithelial ovarian tumors, or germ cell tumors
- Low malignant potential ovarian tumors or mucinous carcinoma
- Diagnosis or treatment of another cancer within 3 years prior to study therapy (with specified exceptions)
- Synchronous high-grade serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium
- History of myelodysplastic syndrome or acute myeloid leukemia
- Radiotherapy within 6 weeks before study treatment
- Previous allogenic bone marrow transplant
- Prior treatment with PARP inhibitors
- Concurrent chemotherapy other than specified HIPEC procedure or anti-neoplastic hormonal therapy
- Recent chronic use of aspirin over 325 mg/day
- History of hypertensive crisis or hypertensive encephalopathy
- Significant cardiovascular disease including recent myocardial infarction, heart failure grade ≥2, uncontrolled arrhythmia, or peripheral vascular disease grade ≥3
- Prior cerebrovascular accidents, transient ischemic attacks, subarachnoid hemorrhage, or posterior reversible encephalopathy syndrome
- History or evidence of bleeding disorders or coagulopathy
- Brain metastases, spinal cord compression, or active central nervous system disease unless treated
- Recent significant traumatic injury or non-healing wounds requiring frequent monitoring
- Prior VEGF therapy-related abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months
- Clinically relevant bowel obstruction or unexplained abdominal free air
- Any disease or condition that contraindicates investigational drug use or poses high risk for complications
- Pregnant or breastfeeding women
- Participation in another clinical study with investigational products (except specified surgical studies)
- Inability to swallow oral medication or gastrointestinal issues affecting absorption
- Known allergy or hypersensitivity to study drugs or their components
- Immunocompromised status including active hepatitis or HIV infection
- Serious uncontrolled medical or psychiatric conditions preventing informed consent or study compliance
AI-Screening
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Trial Site Locations
Total: 88 locations
1
ICO Paul Papin
Angers, France, 49055
Not Yet Recruiting
2
Sainte Catherine Institut du cancer Avignon-Provence
Avignon, France, 84918
Not Yet Recruiting
3
CHRU Besançon - Hôpital Jean Minjoz
Besançon, France, 25000
Not Yet Recruiting
4
Clinique Tivoli-Ducos
Bordeaux, France, 33000
Not Yet Recruiting
5
Institut Bergonié
Bordeaux, France, 33076
Not Yet Recruiting
6
Hôpital Morvan CHRU de Brest
Brest, France, 29200
Not Yet Recruiting
7
HCL - Groupe Hospitalier Est
Bron, France
Not Yet Recruiting
8
Centre François Baclesse
Caen, France, 14076
Actively Recruiting
9
Centre Hospitalier de Cholet
Cholet, France, 49300
Not Yet Recruiting
10
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Not Yet Recruiting
11
CHU de Dijon - Bourgogne
Dijon, France, 21000
Not Yet Recruiting
12
Centre Georges François Leclerc
Dijon, France, 21079
Not Yet Recruiting
13
Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard
Grenoble, France, 38028
Not Yet Recruiting
14
CHU Grenoble-Alpes - Site Nord (La Tronche)
La Tronche, France, 38700
Not Yet Recruiting
15
Clinique Victor Hugo
Le Mans, France, 72000
Not Yet Recruiting
16
Centre Oscar Lambret
Lille, France, 59020
Not Yet Recruiting
17
CHU de Limoges - Hôpital Dupuytren
Limoges, France, 87042
Not Yet Recruiting
18
Centre Léon Bérard
Lyon, France, 69373
Not Yet Recruiting
19
Hôpital Privé Jean Mermoz
Lyon, France, 69373
Not Yet Recruiting
20
HCL - Hôpital de la Croix Rousse
Lyon, France
Not Yet Recruiting
21
Institut Paoli Calmettes
Marseille, France, 13009
Not Yet Recruiting
22
Hôpital Nord Marseille
Marseille, France, 13915
Not Yet Recruiting
23
Institut régional du cancer de Montpellier
Montpellier, France, 34090
Not Yet Recruiting
24
CHU Montpellier - Hôpital Saint Eloi
Montpellier, France, 34295
Not Yet Recruiting
25
Centre Azuréen de Cancérologie
Mougins, France, 06250
Not Yet Recruiting
26
ORACLE - Centre d'Oncologie de Gentilly
Nancy, France, 54000
Not Yet Recruiting
27
Hôpital Privé du Confluent
Nantes, France, 44277
Not Yet Recruiting
28
Centre ONCOGARD - Institut de cancérologie du Gard
Nîmes, France, 30029
Not Yet Recruiting
29
CHR Orléans
Orléans, France, 45100
Not Yet Recruiting
30
Groupe Hospitalier Pitié Salpêtrière
Paris, France, 75013
Not Yet Recruiting
31
Hôpital cochin
Paris, France, 75014
Not Yet Recruiting
32
Hôpital Saint-Joseph
Paris, France, 75014
Not Yet Recruiting
33
Institut Mutualiste Montsouris
Paris, France, 75014
Not Yet Recruiting
34
Hôpital Européen Georges Pompidou
Paris, France, 75015
Not Yet Recruiting
35
Groupe Hospitalier Diaconesses - Croix Saint-Simon
Paris, France, 75020
Not Yet Recruiting
36
Hôpital Tenon
Paris, France, 75020
Not Yet Recruiting
37
HCL - Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)
Pierre-Bénite, France, 69495
Actively Recruiting
38
Centre CARIO - HPCA
Plérin, France, 22190
Not Yet Recruiting
39
CHU de Poitiers - Hôpital de la Milétrie
Poitiers, France, 86021
Not Yet Recruiting
40
Institut Jean Godinot
Reims, France, 51100
Not Yet Recruiting
41
Centre Eugène Marquis
Rennes, France, 35042
Not Yet Recruiting
42
Centre Henri Becquerel
Rouen, France, 76038
Not Yet Recruiting
43
ICO - Centre René Gauducheau
Saint-Herblain, France, 44800
Not Yet Recruiting
44
CHU de Saint-Etienne - Pôle de Cancérologie
Saint-Priest-en-Jarez, France, 42055
Not Yet Recruiting
45
ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, France, 67033
Not Yet Recruiting
46
CHU de Strasbourg Hôpital de Hautepierre
Strasbourg, France
Not Yet Recruiting
47
Institut Claudius Regaud
Toulouse, France, 31059
Actively Recruiting
48
CHU Tours - Hôpital Bretonneau
Tours, France, 37044
Not Yet Recruiting
49
CH Valence
Valence, France, 26000
Not Yet Recruiting
50
Gustave Roussy
Villejuif, France, 94805
Not Yet Recruiting
51
Firenze-Careggi
Florence, Italy, 50134
Not Yet Recruiting
52
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
53
Istituto Europeo di Oncologia (IEO)
Milan, Italy, 20141
Actively Recruiting
54
Ospedale San Gerardo Monza
Monza, Italy, 20900
Actively Recruiting
55
Presidio Ospedaliero di Sondrio
Sondrio, Italy, 23100
Not Yet Recruiting
56
Cancer Institute Hospital Of JFCR
Tokyo, Ariake, Koto, Japan, 135-8550
Actively Recruiting
57
National Cancer Center Hospital East
Kashiwanoha, Chiba, Japan, 277-8577
Not Yet Recruiting
58
Kurume University Hospital Clinical Research Center
Kurume, Fukuoka, Japan, 〒830-0011 6
Actively Recruiting
59
University of Tsukuba Hospital
Tsukuba, Ibaraki-Pref, Japan, 305-8576
Actively Recruiting
60
Niigata Cancer Center Hospital
Niigata, Niigata, Japan, 951-8566
Actively Recruiting
61
Okayama University Hospital
Kita-ku, Okayama-ken, Japan, 700-8558
Not Yet Recruiting
62
Jichi Medical UH
Shimotsuke, Tochigi, Japan, 〒329-0498 3311-1
Not Yet Recruiting
63
Ehime University Hospital
Ehime, Toonshi, Japan, 791-0295
Not Yet Recruiting
64
Yamagata University Hospital
Yamagata, Yamagata, Japan, 990-9585
Not Yet Recruiting
65
Saitama Medical University International Medical Center
Saitama, Japan, 350-1298
Actively Recruiting
66
National University Hospital (NUH)
Singapore, Singapore, 119074
Not Yet Recruiting
67
National Cancer Centre Singapore
Singapore, Singapore, 168583
Not Yet Recruiting
68
Samsung Medical Center
Seoul, Gangnam-gu, South Korea, 06351
Actively Recruiting
69
National Cancer Center
Seoul, Gyeonggi-do, South Korea, 10408
Actively Recruiting
70
National University Hospital
Seoul, Jongno-gu, South Korea, 03080
Actively Recruiting
71
Severance Hospital
Seoul, Seodaemun-gu, South Korea, 03722
Actively Recruiting
72
Asan Medical Center
Seoul, Songpa-gu, South Korea, 05505
Not Yet Recruiting
73
Coruña University Hospital (CHUAC)
A Coruña, Spain, 15006
Actively Recruiting
74
Hospital del Mar
Barcelona, Spain, 08003
Actively Recruiting
75
Hospital Universitari Dexeus
Barcelona, Spain, 08028
Actively Recruiting
76
Hospital San Pedro de Alcantara
Cáceres, Spain, 10003
Actively Recruiting
77
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
78
Hospital Universitario de Jerez
Jerez de la Frontera, Spain, 11407
Not Yet Recruiting
79
Clínica Universidad de Navarra
Madrid, Spain, 28027
Actively Recruiting
80
Hospital Universitario La Paz
Madrid, Spain, 28046
Not Yet Recruiting
81
Hospital Universitario Puerta de Hierro
Madrid, Spain, 28222
Not Yet Recruiting
82
Hospital Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
83
Hospital Universitario Central de Asturias
Oviedo, Spain, 33011
Actively Recruiting
84
Clinica Universidad de Navarra.
Pamplona, Spain, 31008
Not Yet Recruiting
85
Complejo Hospitalario de Navarra
Pamplona, Spain, 31008
Actively Recruiting
86
CHU de Santiago de Compostela
Santiago de Compostela, Spain, 15706
Actively Recruiting
87
Hospital Universitari MutuaTerrassa
Terrassa, Spain, 08221
Actively Recruiting
88
Fundación Investigación Clínico de Valencia.
Valencia, Spain, 46010
Actively Recruiting
Research Team
S
Sidonie Adam
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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