NCT06476184RecruitingPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 5 Jun 2024
- Start date
- 30 Jul 2024
- Primary completion date
- Jun 2027
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Diseases
- Ovarian cancer
- NCT number
- NCT06476184
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 250
- From 30 Jul 2024 to the primary completion date, Jun 2027
- 76 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Histologically confirmed high-grade epithelial (serous, endometrioid, or carcinosarcoma 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-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
- ECOG performance status 0 or 1 (see appendix 2)
- 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),
- 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)
- 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 study including undergoing treatment and scheduled visits and examinations including follow up
- Non-inclusion Criteria:
- 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)
- Previous treatment with bevacizumab during initial standard neo-adjuvant chemotherapy
- Has primary platinum-refractory disease, defined as disease that has progressed during the neo-adjuvant chemotherapy
- 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
- Treatment with other investigational agents in clinical trials during the randomized chemotherapy phase for both arms.
- 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.
- Known psychiatric disorder that would interfere with trial compliance.
- Pregnant or lactating patients or patients expecting to conceive children within the projected duration of the trial.
- Patient deprived of liberty, under guardianship, or under curatorship.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (76)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ICO Paul Papin Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| Sainte Catherine Institut du Cancer Avignon Provence Coordinator of this site? Confirm its status | Avignon | France | Recruiting |
| CH d'Avignon Coordinator of this site? Confirm its status | Avignon | France | Recruiting |
| Hopital de la cote Basque Coordinator of this site? Confirm its status | Bayonne | France | Recruiting |
| CHRU Besançon - Hôpital Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Chu de Brest - Hôpital Cavale Blanche Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| Centre d'Oncologie et de Radiothérapie 37 (ROC37) Coordinator of this site? Confirm its status | Chambray-lès-Tours | France | Recruiting |
| Centre Hospitalier de Cholet Coordinator of this site? Confirm its status | Cholet | France | Recruiting |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Centre Hospitalier Alpes Leman Coordinator of this site? Confirm its status | Contamine-sur-Arve | France | Not yet recruiting |
| Centre Hospitalier Intercommunal de Créteil Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| CHU de DIJON Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Groupe Hospitalier Mutualiste de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| Hôpital André Mignot Coordinator of this site? Confirm its status | Le Chesnay | France | Recruiting |
| CHRU de Lille Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| CHU de Limoges-Hopital Dupuytren Coordinator of this site? Confirm its status | Limoges | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Hôpital Privé Jean Mermoz Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Hôpital de la Croix Rousse Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| ICM Val d'Aurelle Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHRU de Montpellier - Hôpital Saint-Eloi Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Centre Azuréen de Cancérologie Coordinator of this site? Confirm its status | Mougins | France | Recruiting |
| Hôpital Privé du Confluent Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Institut de Cancérologie du Gard - CHU de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
| Hopital Européen George Pompidou Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Groupe Hospitalier Diaconesses Croix Saint-Simon Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier General de Pau Coordinator of this site? Confirm its status | Pau | France | Recruiting |
| HCL Centre Hospitalier Lyon Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Hôpital de Poissy-Saint-Germain-en-Laye Coordinator of this site? Confirm its status | Poissy | France | Not yet recruiting |
| Institut Jean Godinot Coordinator of this site? Confirm its status | Reims | France | Recruiting |
| Centre Eugène Marquis Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Hôpital privé de la Loire Coordinator of this site? Confirm its status | Saint-Etienne | France | Not yet recruiting |
| Institut de Cancérologie de l'Ouest (ICO) Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| CHU Saint-Etienne - Pôle de Cancérologie Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| ICANS - Institut de cancérologie Strasbourg Europe Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| CHU Strasbourg - Hôpital de Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Hopital Foch Coordinator of this site? Confirm its status | Suresnes | France | Recruiting |
| Hôpitaux du Léman - site Thonon-les-Bains Coordinator of this site? Confirm its status | Thonon-les-Bains | France | Not yet recruiting |
| Oncopole Claudius Regaud IUCT ONCOPOLE Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Centre Hospitalier de Valence Coordinator of this site? Confirm its status | Valence | France | Recruiting |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria Coordinator of this site? Confirm its status | Alessandria | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Not yet recruiting |
| Alessandro Manzoni Hospital Coordinator of this site? Confirm its status | Lecco | Italy | Not yet recruiting |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ulss 3 Serenissima Coordinator of this site? Confirm its status | Venice | Italy | Not yet recruiting |
| The University of Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Not yet recruiting |
| Fukushima Medical University Hospital Coordinator of this site? Confirm its status | Fukushima | Japan | Recruiting |
| Saitama Medical University International Medical Center Coordinator of this site? Confirm its status | Hidaka | Japan | Recruiting |
| Hirosaki University Hospital Coordinator of this site? Confirm its status | Hirosaki | Japan | Not yet recruiting |
| The Jikei University Kashiwa Hospital Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| St. Marianna University Hospital Coordinator of this site? Confirm its status | Kawasaki | Japan | Recruiting |
| Dokkyo Medical University Saitama Medical Center Coordinator of this site? Confirm its status | Koshigaya | Japan | Not yet recruiting |
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume | Japan | Not yet recruiting |
| Nagoya University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Kindai University Hospital Coordinator of this site? Confirm its status | Sayama | Japan | Recruiting |
| Tohoku University Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| Osaka Medical and Pharmaceutical University Hospital Coordinator of this site? Confirm its status | Takatsuki | Japan | Not yet recruiting |
| The Jikei University Daisan Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Not yet recruiting |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Not yet recruiting |
| The Jikei University Katsushika Medical Center Coordinator of this site? Confirm its status | Tokyo | Japan | Not yet recruiting |
| The Jikei University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Not yet recruiting |
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Not yet recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
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This page is information, not medical advice. Discuss any trial with your doctor.