Clinical Trials in the Netherlands / NCT06476184
Recruiting Phase 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

NCT06476184 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 3
Started
2024-07-30
Last updated
2026-08-04

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

Carboplatin →Paclitaxel →

Carboplatin: Patients will be randomized 1:1: * Experimental arm: Densification of the chemotherapy administration dose and dosing schedule of carboplatin-paclitaxel (carboplatin AUC 5 every 3 weeks on day 1 and paclitaxel 80 mg/m2 every week, on day 1, day 8, and day 15, with 3 week-cycles) for 3 cycles * Standard arm: Continuation of the same 3-weekly carboplatin-paclitaxel, as administered during the neo-adjuvant chemotherapy

Paclitaxel: Patients will be randomized 1:1: * Experimental arm: Densification of the chemotherapy administration dose and dosing schedule of carboplatin-paclitaxel (carboplatin AUC 5 every 3 weeks on day 1 and paclitaxel 80 mg/m2 every week, on day 1, day 8, and day 15, with 3 week-cycles) for 3 cycles * Standard arm: Continuation of the same 3-weekly carboplatin-paclitaxel, as administered during the neo-adjuvant chemotherapy

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 Non-inclusion Criteria: 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 during the randomized chemotherapy phase for both arms. 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.

Primary outcome measure(s)

Trial sites (76)

FacilityCityRegionStatus
ICO Paul Papin Angers France Recruiting
CH d'Avignon Avignon France Recruiting
Sainte-Catherine Institut du Cancer Avignon-Provence Avignon France Recruiting
Hôpital de la Côte Basque Bayonne France Recruiting
CHRU Besançon - Hôpital Jean Minjoz Besançon France Recruiting
Institut Bergonié Bordeaux France Recruiting
CHU de BREST - Hôpital Cavale Blanche Brest France Recruiting
Centre François Baclesse Caen France Recruiting
Centre d'Oncologie et de Radiothérapie 37 (ROC37) Chambray-lès-Tours France Recruiting
Centre Hospitalier de Cholet Cholet France Recruiting
Centre Jean Perrin Clermont-Ferrand France Recruiting
Centre Hospitalier Alpes Leman Contamine-sur-Arve France Not Yet Recruiting
Centre Hospitalier Intercommunal de Créteil Créteil France Recruiting
Centre Georges François Leclerc Dijon France Recruiting
CHU de Dijon Dijon France Recruiting
Groupe Hospitalier Mutualiste de Grenoble Grenoble France Recruiting
Hôpital André Mignot Le Chesnay France Recruiting
CHRU de Lille Lille France Not Yet Recruiting
Centre Oscar Lambret Lille France Recruiting
CHU de Limoges - Hôpital Dupuytren Limoges France Recruiting
Hôpital de la Croix Rousse Lyon France Not Yet Recruiting
Centre Léon Bérard Lyon France Recruiting
Hôpital Privé Jean Mermoz Lyon France Recruiting
Hôpital de la Timone Marseille France Not Yet Recruiting
CHRU de Montpellier - Hôpital Saint-Eloi Montpellier France Recruiting
ICM Val d'Aurelle Montpellier France Recruiting
Centre Azuréen de Cancérologie Mougins France Recruiting
Hôpital Privé du Confluent Nantes France Recruiting
Centre Antoine Lacassagne Nice France Recruiting
Institut de Cancérologie du Gard - CHU de Nîmes Nîmes France Recruiting
Groupe Hospitalier Diaconesses - Croix Saint-Simon Paris France Recruiting
Hôpital Cochin Paris France Recruiting
Hôpital Européen George Pompidou Paris France Recruiting
Institut Curie Paris France Recruiting
Centre Hospitalier Général de Pau Pau France Recruiting
HCL - Centre Hospitalier Lyon Sud Pierre-Bénite France Recruiting
Hôpital de Poissy-Saint-Germain-en-Laye Poissy France Not Yet Recruiting
Institut Jean Godinot Reims France Recruiting
Centre Eugène Marquis Rennes France Recruiting
Hôpital Privé de la Loire Saint-Etienne France Not Yet Recruiting

+ 36 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06476184 on ClinicalTrials.gov ↗ ← All trials in the Netherlands