Informations générales (source: ClinicalTrials.gov)
A Pragmatic Randomized Phase III Trial to Assess the 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
Interventional
Phase 3
ARCAGY/ GINECO GROUP (Voir sur ClinicalTrials)
juillet 2024
décembre 2028
05 décembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Asmahane BENMAZIANE TEILLET | 11/05/2026 07:26:35 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Sixtine DE PERCIN | Contact (sur clinicalTrials) | |||
| CH DE VERSAILLES SITE ANDRE MIGNOT | Marie-Sophie THIS | Contact (sur clinicalTrials) | |||
| CHI DE CRETEIL | Zineb SELLAM-CHORFI | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT CURIE | Manuel RODRIGUES | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Alexandra LEARY | Contact (sur clinicalTrials) | |||
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Frédéric SELLE | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Philippe FOLLANA | Contact (sur clinicalTrials) | |||
| Centre Azuréen de Cancérologie - 06250 - Mougins - France | Rémy LARGILLIER | Contact (sur clinicalTrials) | |||
| Centre CARIO - HPCA - 22190 - Plérin - France | Anne-Claire HARDY-BESSARD | Contact (sur clinicalTrials) | |||
| Centre d'Oncologie et de Radiothérapie 37 (ROC37) - 37170 - Chambray-lès-Tours - France | Pierre COMBE | Contact (sur clinicalTrials) | |||
| Centre Eugène Marquis - 35042 - Rennes - France | Thibault DE LA MOTTE ROUGE | Contact (sur clinicalTrials) | |||
| Centre François Baclesse - 14076 - Caen - France | Florence JOLY | Contact (sur clinicalTrials) | |||
| Centre Georges François Leclerc - 21079 - Dijon - France | Jean-David FUMET | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Alpes Leman - 74130 - Contamine-sur-arve - France | Mansour RASTKHAH | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Cholet - 49300 - Cholet - France | Sylvère GUILLEMOIS | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Valence - 26953 - Valence - France | Rim BATTI | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Général de Pau - 64046 - Pau - France | Kevin BOURCIER | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - 63011 - Clermont-ferrand - France | Laure VACHER | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - 69373 - Lyon - France | Philippe TOUSSAINT | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - 59020 - Lille - France | Stéphanie BECOURT | Contact (sur clinicalTrials) | |||
| CH d'Avignon - 84902 - Avignon - France | Nathan AOUIZERAT | Contact (sur clinicalTrials) | |||
| CHRU Besançon - Hôpital Jean Minjoz - 25030 - Besançon - France | Laura MANSI | Contact (sur clinicalTrials) | |||
| CHRU de Lille - 59000 - Lille - France | Yohan KERBAGE | Contact (sur clinicalTrials) | |||
| CHRU de Montpellier - Hôpital Saint-Eloi - 34059 - Montpellier - France | Clothilde LINDET-BOURGEOIS | Contact (sur clinicalTrials) | |||
| CHU de BREST - Hôpital Cavale Blanche - 29200 - Brest - France | Laura DEIANA | Contact (sur clinicalTrials) | |||
| CHU de Dijon - 21079 - Dijon - France | Marie CHAIX | Contact (sur clinicalTrials) | |||
| CHU de Limoges - Hôpital Dupuytren - 87042 - Limoges - France | Laurence VENAT-BOUVET | Contact (sur clinicalTrials) | |||
| CHU Saint-Etienne - Pôle de Cancérologie - 42271 - Saint-priest-en-jarez - France | Pauline CORBAUX | Contact (sur clinicalTrials) | |||
| Clinique Pasteur - 31300 - Toulouse - France | Mathilde MARTINEZ | Contact (sur clinicalTrials) | |||
| Groupe Hospitalier Mutualiste de Grenoble - 38028 - Grenoble - France | Elise BONNET | Contact (sur clinicalTrials) | |||
| HCL - Centre Hospitalier Lyon Sud - 69495 - Pierre-Bénite - France | Benoit YOU | Contact (sur clinicalTrials) | |||
| Hôpital de la Côte Basque - 64100 - Bayonne - France | Thomas GRELLETY | Contact (sur clinicalTrials) | |||
| Hôpital de Poissy-Saint-Germain-en-Laye - 78303 - Poissy - France | Gabriela TOSSEN | Contact (sur clinicalTrials) | |||
| Hôpital Privé de la Loire - 42100 - Saint-etienne - France | Romain RIVOIRARD | Contact (sur clinicalTrials) | |||
| Hôpital Privé du Confluent - 44202 - Nantes - France | Cyriac BLONZ | Contact (sur clinicalTrials) | |||
| Hôpital Privé Jean Mermoz - 69373 - Lyon - France | Olfa DERBEL MILED | Contact (sur clinicalTrials) | |||
| Hôpitaux du Léman - site Thonon-les-Bains - 74203 - Thonon-les-bains - France | Fanny POMMERET | Contact (sur clinicalTrials) | |||
| ICANS - Institut de cancérologie Strasbourg Europe - 67033 - Strasbourg - France | Lauriane EBERST | Contact (sur clinicalTrials) | |||
| ICM Val d'Aurelle - 34298 - Montpellier - France | Stanislas QUESADA | Contact (sur clinicalTrials) | |||
| ICO Paul Papin - 49055 - Angers - France | Sophie ABADIE-LACOURTOISIE | Contact (sur clinicalTrials) | |||
| Institut Bergonié - 33076 - Bordeaux - France | Coriolan LEBRETON | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - ICO - 44805 - Saint-Herblain - France | Dominique BERTON | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie du Gard - CHU de Nîmes - 30029 - Nîmes - France | Frédéric FITENI | Contact (sur clinicalTrials) | |||
| Oncopole Claudius Régaud - IUCT Oncopole - 31059 - Toulouse - France | Gwénaël FERRON | Contact (sur clinicalTrials) | |||
| Sainte-Catherine Institut du Cancer Avignon-Provence - 84918 - Avignon - France | Julien GRENIER | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
1. Histologically confirmed high-grade epithelial (serous, endometrioid, or
carcinosarcoma with a ≥30% epithelial tumor component) ovarian, primary peritoneal,
or fallopian-tube carcinoma
2. Adult patient aged ≥ 18 years old
3. Advanced stage III or IV disease
4. Treated with 3 to 4 neo-adjuvant cycles of standard 3-weekly carboplatin-paclitaxel
regimen in first-line setting, and characterized by:
- Unfavorable standardized KELIMTM score < 1.0 calculated with the KELIMTM
academic tool 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 interval
debulking surgery attempt, or disease not operated at all because considered
not amenable to complete surgery by surgeon) Of note, a pre-screening inclusion
before the start of neo-adjuvant chemotherapy is encouraged as a way of
prospectively assessing the CA-125 longitudinal kinetics and surgery
evaluation, and subsequently selecting the patients for the randomization
sequence
5. ECOG performance status 0 or 1 (see appendix 2)
6. Adequate organ and bone marrow function for weekly-dense chemotherapy: red blood
cells (baseline Hemoglobin ≥8 g/dL without red blood cell transfusion within 3 weeks
before the blood work), white blood cells (Absolute neutrophil count (ANC) ≥1500
cells/mm3) and platelets (Platelet count ≥100,000/mm3),
7. Adequate renal and liver functions
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 ×
upper limit of normal (ULN), or ≤5 × ULN in context of liver metastases
- Total bilirubin ≤1.5 × ULN (patients with Gilbert's are eligible if total
bilirubin ≤3 × ULN)
- Albumin ≥3 g/dL
- Creatinine clearance ≥40 mL/min/1.73 m2 (measured or estimated, ideally with
CKD-EPI formula on https://www.kidney.org/professionals/kdoqi/gfr_calculator)
8. Patients who gave its written informed consent to participate to the study
9. Patients affiliated to a social insurance regime
10. Patients willing and able to comply with the protocol for the duration of the study
including undergoing treatment and scheduled visits and examinations including
follow up
1. Histologically confirmed high-grade epithelial (serous, endometrioid, or
carcinosarcoma with a ≥30% epithelial tumor component) ovarian, primary peritoneal,
or fallopian-tube carcinoma
2. Adult patient aged ≥ 18 years old
3. Advanced stage III or IV disease
4. Treated with 3 to 4 neo-adjuvant cycles of standard 3-weekly carboplatin-paclitaxel
regimen in first-line setting, and characterized by:
- Unfavorable standardized KELIMTM score < 1.0 calculated with the KELIMTM
academic tool 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 interval
debulking surgery attempt, or disease not operated at all because considered
not amenable to complete surgery by surgeon) Of note, a pre-screening inclusion
before the start of neo-adjuvant chemotherapy is encouraged as a way of
prospectively assessing the CA-125 longitudinal kinetics and surgery
evaluation, and subsequently selecting the patients for the randomization
sequence
5. ECOG performance status 0 or 1 (see appendix 2)
6. Adequate organ and bone marrow function for weekly-dense chemotherapy: red blood
cells (baseline Hemoglobin ≥8 g/dL without red blood cell transfusion within 3 weeks
before the blood work), white blood cells (Absolute neutrophil count (ANC) ≥1500
cells/mm3) and platelets (Platelet count ≥100,000/mm3),
7. Adequate renal and liver functions
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 ×
upper limit of normal (ULN), or ≤5 × ULN in context of liver metastases
- Total bilirubin ≤1.5 × ULN (patients with Gilbert's are eligible if total
bilirubin ≤3 × ULN)
- Albumin ≥3 g/dL
- Creatinine clearance ≥40 mL/min/1.73 m2 (measured or estimated, ideally with
CKD-EPI formula on https://www.kidney.org/professionals/kdoqi/gfr_calculator)
8. Patients who gave its written informed consent to participate to the study
9. Patients affiliated to a social insurance regime
10. Patients willing and able to comply with the protocol for the duration of the study
including undergoing treatment and scheduled visits and examinations including
follow up
1. Low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed
tumors containing any of these histologies, or low-grade or borderline ovarian
tumor. Contraindication to the drugs assessed in the SALVOVAR trial (carboplatin,
paclitaxel, GCSF)
2. Previous treatment with bevacizumab during initial standard neo-adjuvant
chemotherapy
3. Has primary platinum-refractory disease, defined as disease that has progressed
during the neo-adjuvant chemotherapy
4. Patients with concomitant cancer, except: adequately treated non-melanoma skin
cancer, curatively treated in-situ cancer of the cervix, or other solid tumors
curatively treated with no evidence of disease for ≥ 5 years
5. Treatment with other investigational agents in clinical trials.
6. Clinically significant uncontrolled condition(s) which, in the opinion of the
Investigator, may confound the results of the trial or interfere with the patient's
safety 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 2
weeks 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, symptomatic
ascites/effusions requiring paracentesis or thoracentesis ≤30 days of study
entry.
7. Known psychiatric disorder that would interfere with trial compliance.
8. Pregnant or lactating patients or patients expecting to conceive children within the
projected duration of the trial.
9. Patient deprived of liberty, under guardianship, or under curatorship.