Actively Recruiting
Utility of Adjusting Chemotherapy Dose & Dosing Schedule With the SALVage Weekly Dose-dense Regimen in Patients With Poor Prognostic OVARian Cancers Based on the Tumor Unfavorable Primary Chemosensitivity and Incomplete Debulking Surgery
Led by ARCAGY/ GINECO GROUP · Updated on 2025-12-05
250
Participants Needed
72
Research Sites
226 weeks
Total Duration
On this page
Sponsors
A
ARCAGY/ GINECO GROUP
Lead Sponsor
H
Horizon 2020 - European Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
SALVOVAR will be a pragmatic open-label multicenter randomized phase III trial (ratio 1:1) comparing the efficacy of the salvage weekly dose-dense regimen with those of the continuation of the standard regimen.
CONDITIONS
Official Title
Utility of Adjusting Chemotherapy Dose & Dosing Schedule With the SALVage Weekly Dose-dense Regimen in Patients With Poor Prognostic OVARian Cancers Based on the Tumor Unfavorable Primary Chemosensitivity and Incomplete Debulking Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed high-grade epithelial (serous, endometrioid, or carcinosarcoma with 30% epithelial tumor component) ovarian, primary peritoneal, or fallopian-tube carcinoma
- Adult patient aged 18 years old
- Advanced stage III or IV disease
- Treated with 3 to 4 neo-adjuvant cycles of standard 3-weekly carboplatin-paclitaxel regimen in first-line setting
- Unfavorable standardized KELIMTM score < 1.0 indicating poor primary chemosensitivity
- Not amenable to complete interval debulking surgery (incomplete surgery or no surgery due to tumor extent)
- ECOG performance status 0 or 1
- Adequate organ and bone marrow function for weekly-dense chemotherapy including hemoglobin 8 g/dL without recent transfusion, ANC 1500 cells/mm3, platelet count 100,000/mm3
- Adequate renal and liver functions: AST and ALT 2.5 times upper limit of normal (ULN) or 5 times ULN with liver metastases, total bilirubin 1.5 times ULN (or 3 times ULN if Gilbert's syndrome), albumin 3 g/dL, creatinine clearance 40 mL/min/1.73 m2
- Written informed consent
- Affiliated to a social insurance regime
- Willing and able to comply with protocol including treatment and scheduled visits
You will not qualify if you...
- Low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing these histologies, or low-grade or borderline ovarian tumor
- Contraindication to carboplatin, paclitaxel, or GCSF
- Previous treatment with bevacizumab during initial neo-adjuvant chemotherapy
- Primary platinum-refractory disease (progression during neo-adjuvant chemotherapy)
- Concomitant cancer except adequately treated non-melanoma skin cancer, treated in-situ cervical cancer, or other solid tumors treated with no evidence of disease for 5 years
- Treatment with other investigational agents in clinical trials
- Clinically significant uncontrolled conditions such as unstable angina, recent myocardial infarction, severe arrhythmia, heart failure, cirrhosis
- Active infection requiring IV therapy within 2 weeks
- Gastric outlet or small bowel obstruction or symptomatic ascites/effusions requiring paracentesis/thoracentesis within specified timeframes
- Known psychiatric disorder interfering with compliance
- Pregnant, lactating, or planning pregnancy during study
- Patient deprived of liberty, under guardianship, or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 72 locations
1
ICO Paul Papin
Angers, France, 49055
Actively Recruiting
2
CH d'Avignon
Avignon, France, 84902
Actively Recruiting
3
Sainte-Catherine Institut du Cancer Avignon-Provence
Avignon, France, 84918
Actively Recruiting
4
Hôpital de la Côte Basque
Bayonne, France, 64100
Actively Recruiting
5
CHRU Besançon - Hôpital Jean Minjoz
Besançon, France, 25030
Actively Recruiting
6
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
7
CHU de BREST - Hôpital Cavale Blanche
Brest, France, 29200
Actively Recruiting
8
Centre François Baclesse
Caen, France, 14076
Actively Recruiting
9
Centre d'Oncologie et de Radiothérapie 37 (ROC37)
Chambray-lès-Tours, France, 37170
Actively Recruiting
10
Centre Hospitalier de Cholet
Cholet, France, 49300
Actively Recruiting
11
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
12
Centre Hospitalier Alpes Leman
Contamine-sur-Arve, France, 74130
Not Yet Recruiting
13
Centre Hospitalier Intercommunal de Créteil
Créteil, France, 94010
Actively Recruiting
14
Centre Georges François Leclerc
Dijon, France, 21079
Actively Recruiting
15
CHU de Dijon
Dijon, France, 21079
Actively Recruiting
16
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France, 38028
Actively Recruiting
17
Hôpital André Mignot
Le Chesnay, France, 78157
Not Yet Recruiting
18
CHRU de Lille
Lille, France, 59000
Not Yet Recruiting
19
Centre Oscar Lambret
Lille, France, 59020
Not Yet Recruiting
20
CHU de Limoges - Hôpital Dupuytren
Limoges, France, 87042
Actively Recruiting
21
Hôpital de la Croix Rousse
Lyon, France, 69229
Not Yet Recruiting
22
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
23
Hôpital Privé Jean Mermoz
Lyon, France, 69373
Actively Recruiting
24
Hôpital de la Timone
Marseille, France, 13005
Not Yet Recruiting
25
CHRU de Montpellier - Hôpital Saint-Eloi
Montpellier, France, 34059
Not Yet Recruiting
26
ICM Val d'Aurelle
Montpellier, France, 34298
Not Yet Recruiting
27
Centre Azuréen de Cancérologie
Mougins, France, 06250
Actively Recruiting
28
Hôpital Privé du Confluent
Nantes, France, 44202
Actively Recruiting
29
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
30
Institut de Cancérologie du Gard - CHU de Nîmes
Nîmes, France, 30029
Actively Recruiting
31
Groupe Hospitalier Diaconesses - Croix Saint-Simon
Paris, France, 75012
Actively Recruiting
32
Hôpital Cochin
Paris, France, 75014
Actively Recruiting
33
Hôpital Européen George Pompidou
Paris, France, 75015
Not Yet Recruiting
34
Institut Curie
Paris, France, 75248
Actively Recruiting
35
Centre Hospitalier Général de Pau
Pau, France, 64046
Actively Recruiting
36
HCL - Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
37
Hôpital de Poissy-Saint-Germain-en-Laye
Poissy, France, 78303
Not Yet Recruiting
38
Institut Jean Godinot
Reims, France, 51056
Not Yet Recruiting
39
Centre Eugène Marquis
Rennes, France, 35042
Actively Recruiting
40
Hôpital Privé de la Loire
Saint-Etienne, France, 42100
Not Yet Recruiting
41
Institut de Cancérologie de l'Ouest - ICO
Saint-Herblain, France, 44805
Actively Recruiting
42
CHU Saint-Etienne - Pôle de Cancérologie
Saint-Priest-en-Jarez, France, 42271
Actively Recruiting
43
ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, France, 67033
Actively Recruiting
44
CHU Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67098
Not Yet Recruiting
45
Hôpital Foch
Suresnes, France, 92151
Actively Recruiting
46
Hôpitaux du Léman - site Thonon-les-Bains
Thonon-les-Bains, France, 74203
Not Yet Recruiting
47
Oncopole Claudius Régaud - IUCT Oncopole
Toulouse, France, 31059
Actively Recruiting
48
Clinique Pasteur
Toulouse, France, 31300
Actively Recruiting
49
Centre Hospitalier de Valence
Valence, France, 26953
Actively Recruiting
50
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
51
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Alessandria, Italy, 15121
Not Yet Recruiting
52
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Bologna, Italy, 40138
Not Yet Recruiting
53
Careggi University Hospital
Florence, Italy, 50134
Not Yet Recruiting
54
Alessandro Manzoni Hospital
Lecco, Italy, 23900
Not Yet Recruiting
55
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy, 20141
Not Yet Recruiting
56
Azienda Ulss 3 Serenissima
Venice, Italy, 30174
Not Yet Recruiting
57
The University of Tokyo Hospital
Bunkyō City, Japan
Not Yet Recruiting
58
Fukushima Medical University Hospital
Fukushima, Japan
Not Yet Recruiting
59
Saitama Medical University International Medical Center
Hidaka, Japan
Actively Recruiting
60
Hirosaki University Hospital
Hirosaki, Japan
Not Yet Recruiting
61
The Jikei University Kashiwa Hospital
Kashiwa, Japan
Not Yet Recruiting
62
St. Marianna University Hospital
Kawasaki, Japan
Not Yet Recruiting
63
Dokkyo Medical University Saitama Medical Center
Koshigaya, Japan
Not Yet Recruiting
64
Kurume University Hospital
Kurume, Japan
Not Yet Recruiting
65
Nagoya University Hospital
Nagoya, Japan
Not Yet Recruiting
66
Kindai University Hospital
Sayama, Japan
Not Yet Recruiting
67
Tohoku University Hospital
Sendai, Japan
Not Yet Recruiting
68
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Japan
Not Yet Recruiting
69
The Cancer Institute Hospital Of JFCR
Tokyo, Japan
Not Yet Recruiting
70
The Jikei University Daisan Hospital
Tokyo, Japan
Not Yet Recruiting
71
The Jikei University Hospital
Tokyo, Japan
Not Yet Recruiting
72
The Jikei University Katsushika Medical Center
Tokyo, Japan
Not Yet Recruiting
Research Team
M
Marine COGNAT
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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