Phase
Condition
Ovarian Cancer
Pelvic Cancer
Ovarian Cysts
Treatment
Carboplatin
Paclitaxel
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed high-grade epithelial (serous, endometrioid, orcarcinosarcoma with a ≥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-paclitaxelregimen in first-line setting, and characterized by:
Unfavorable standardized KELIMTM score < 1.0 calculated with the KELIM academictool and available for free on internet site (https://www.biomarker-kinetics.org/CA-125-neo) (poor primary chemosensitivity)
Not amenable to complete interval debulking surgery (incomplete intervaldebulking surgery attempt, or disease not operated at all because considerednot amenable to complete surgery by surgeon) Of note, a pre-screening inclusionbefore the start of neo-adjuvant chemotherapy is encouraged as a way ofprospectively assessing the CA-125 longitudinal kinetics and surgeryevaluation, and subsequently selecting the patients for the randomizationsequence
ECOG performance status 0 or 1 (see appendix 2)
Adequate organ and bone marrow function for weekly-dense chemotherapy: red bloodcells (baseline Hemoglobin ≥8 g/dL without red blood cell transfusion within 3 weeksbefore the blood work), white blood cells (Absolute neutrophil count (ANC) ≥1500cells/mm3) and platelets (Platelet count ≥100,000/mm3),
Adequate renal and liver functions
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × upperlimit of normal (ULN), or ≤5 × ULN in context of liver metastases
Total bilirubin ≤1.5 × ULN (patients with Gilbert's are eligible if totalbilirubin ≤3 × ULN)
Albumin ≥3 g/dL
Creatinine clearance ≥40 mL/min/1.73 m2 (measured or estimated, ideally withCKD-EPI formula on https://www.kidney.org/professionals/kdoqi/gfr_calculator)
Patients who gave its written informed consent to participate to the study
Patients affiliated to a social insurance regime
Patients willing and able to comply with the protocol for the duration of the studyincluding undergoing treatment and scheduled visits and examinations includingfollow up
Exclusion
Exclusion Criteria:
Low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixedtumors containing any of these histologies, or low-grade or borderline ovariantumor. No contraindication to the drugs assessed in the SALVOVAR trial (carboplatin,paclitaxel, GCSF)
Previous treatment with bevacizumab during initial standard neo-adjuvantchemotherapy
Has primary platinum-refractory disease, defined as disease that has progressedduring the neo-adjuvant chemotherapy
Patients with concomitant cancer, except: adequately treated non-melanoma skincancer, curatively treated in-situ cancer of the cervix, or other solid tumorscuratively treated with no evidence of disease for ≥ 5 years
Treatment with other investigational agents in clinical trials.
Clinically significant uncontrolled condition(s) which, in the opinion of theInvestigator, may confound the results of the trial or interfere with the patient'ssafety or participation, including but not limited to:
Unstable angina.
Myocardial infarction within 6 months of first dose.
Uncontrolled and/or severe concomitant diseases (uncontrolled hypertension, ≥Grade 3 (per CTCAE v5.0) arrhythmia, heart failure, cirrhosis).
Active infectious disease requiring IV therapy (bacteria, viruses) within 2weeks of first dose.
Gastric-outlet obstruction.
Small bowel obstruction (SBO) defined as computed tomography (CT) scan showing:Dilated loops of small bowel ≤12 weeks of study entry, symptomaticascites/effusions requiring paracentesis or thoracentesis ≤30 days of studyentry.
Known psychiatric disorder that would interfere with trial compliance.
Pregnant or lactating patients or patients expecting to conceive children within theprojected duration of the trial.
Patient deprived of liberty, under guardianship, or under curatorship.
Study Design
Study Description
Connect with a study center
ICO Paul Papin
Angers, 49055
FranceActive - Recruiting
Sainte-Catherine Institut du Cancer Avignon-Provence
Avignon, 84918
FranceActive - Recruiting
Hôpital de la Côte Basque
Bayonne, 64100
FranceActive - Recruiting
CHRU Besançon - Hôpital Jean Minjoz
Besançon, 25030
FranceActive - Recruiting
Institut Bergonié
Bordeaux, 33076
FranceActive - Recruiting
CHU de BREST - Hôpital Cavale Blanche
Brest, 29200
FranceActive - Recruiting
Centre François Baclesse
Caen, 14076
FranceSite Not Available
Centre d'Oncologie et de Radiothérapie 37 (ROC37)
Chambray-lès-Tours, 37170
FranceActive - Recruiting
Centre Jean Perrin
Clermont-ferrand, 63011
FranceSite Not Available
Centre Hospitalier Alpes Leman
Contamine-sur-arve, 74130
FranceSite Not Available
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
FranceSite Not Available
CHU de Dijon
Dijon, 21079
FranceActive - Recruiting
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, 38028
FranceSite Not Available
Hôpital André Mignot
Le Chesnay, 78157
FranceSite Not Available
CHU de Limoges - Hôpital Dupuytren
Limoges, 87042
FranceSite Not Available
Centre Léon Bérard
Lyon, 69373
FranceSite Not Available
Hôpital Privé Jean Mermoz
Lyon, 69373
FranceSite Not Available
ICM Val d'Aurelle
Montpellier, 34298
FranceSite Not Available
Centre Azuréen de Cancérologie
Mougins, 06250
FranceSite Not Available
Hôpital Privé du Confluent
Nantes, 44202
FranceActive - Recruiting
Centre Antoine Lacassagne
Nice, 06189
FranceActive - Recruiting
Institut de Cancérologie du Gard - CHU de Nîmes
Nîmes, 30029
FranceSite Not Available
Groupe Hospitalier Diaconesses - Croix Saint-Simon
Paris, 75012
FranceSite Not Available
Hôpital Cochin
Paris, 75014
FranceSite Not Available
Institut Curie
Paris, 75248
FranceSite Not Available
Centre Hospitalier Général de Pau
Pau, 64046
FranceSite Not Available
HCL - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
FranceActive - Recruiting
Centre CARIO - HPCA
Plérin, 22190
FranceSite Not Available
Centre Eugène Marquis
Rennes, 35042
FranceSite Not Available
Institut de Cancérologie de l'Ouest - ICO
Saint-Herblain, 44805
FranceSite Not Available
ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, 67033
FranceActive - Recruiting
Clinique Pasteur
Toulouse, 31300
FranceActive - Recruiting
IUCT Oncopole - Institut Claudius Régaud
Toulouse, 31059
FranceSite Not Available
Centre Hospitalier de Valence
Valence, 26953
FranceSite Not Available
Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Alexandrie, 15121
ItalySite Not Available
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Bologna, 40138
ItalySite Not Available
Careggi University Hospital
Florence, 50134
ItalySite Not Available
Alessandro Manzoni Hospital
Lecco, 23900
ItalySite Not Available
Istituto Europeo Di Oncologia S.r.l.
Milan, 20141
ItalySite Not Available
Azienda Ulss 3 Serenissima
Venice, 30174
ItalySite Not Available
The University of Tokyo Hospital
Bunkyo,
JapanSite Not Available
Fukushima Medical University Hospital
Fukushima,
JapanSite Not Available
Saitama Medical University International Medical Center
Hidaka,
JapanActive - Recruiting
Hirosaki University Hospital
Hirosaki,
JapanSite Not Available
The Jikei University Kashiwa Hospital
Kashiwa,
JapanSite Not Available
St. Marianna University Hospital
Kawasaki,
JapanSite Not Available
Dokkyo Medical University Saitama Medical Center
Koshigaya,
JapanSite Not Available
Kurume University Hospital
Kurume,
JapanSite Not Available
Nagoya University Hospital
Nagoya,
JapanSite Not Available
Kindai University Hospital
Osakasayama,
JapanSite Not Available
Tohoku University Hospital
Sendai,
JapanSite Not Available
Osaka Medical and Pharmaceutical University Hospital
Takatsuki,
JapanSite Not Available
The Cancer Institute Hospital Of JFCR
Tokyo,
JapanSite Not Available
The Jikei University Daisan Hospital
Tokyo,
JapanSite Not Available
The Jikei University Hospital
Tokyo,
JapanSite Not Available
The Jikei University Katsushika Medical Center
Tokyo,
JapanSite Not Available
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