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

Recruiting now · Phase 3

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT06476184

Run by

ARCAGY/ GINECO GROUP

People needed

250

Starts

2024-07-30

Expected to finish

2028-06-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Centre Azuréen de Cancérologie — Mougins, France (enrolling)
• Hôpital Privé du Confluent — Nantes, France (enrolling)
• CH d'Avignon — Avignon, France (enrolling)
• ICM Val d'Aurelle — Montpellier, France (enrolling)
• ICO Paul Papin — Angers, France (enrolling)
• CHU de BREST - Hôpital Cavale Blanche — Brest, France (enrolling)
• Centre François Baclesse — Caen, France (enrolling)
• Hôpital de la Côte Basque — Bayonne, France (enrolling)
• CHRU Besançon - Hôpital Jean Minjoz — Besançon, France (enrolling)
• Centre Jean Perrin — Clermont-Ferrand, France (enrolling)
• Sainte-Catherine Institut du Cancer Avignon-Provence — Avignon, France (enrolling)
• Centre Hospitalier Intercommunal de Créteil — Créteil, France (enrolling)
• Centre Georges François Leclerc — Dijon, France (enrolling)
• CHU de Dijon — Dijon, France (enrolling)
• Groupe Hospitalier Mutualiste de Grenoble — Grenoble, France (enrolling)
• Hôpital André Mignot — Le Chesnay, France (enrolling)
• Centre d'Oncologie et de Radiothérapie 37 (ROC37) — Chambray-lès-Tours, France (enrolling)
• Centre Oscar Lambret — Lille, France (enrolling)
• CHU de Limoges - Hôpital Dupuytren — Limoges, France (enrolling)
• Centre Hospitalier de Cholet — Cholet, France (enrolling)
• Centre Léon Bérard — Lyon, France (enrolling)
• Hôpital Privé Jean Mermoz — Lyon, France (enrolling)
• Institut Bergonié — Bordeaux, France (enrolling)
• CHRU de Montpellier - Hôpital Saint-Eloi — Montpellier, France (enrolling)
• Centre Antoine Lacassagne — Nice, France (enrolling)

Full record on ClinicalTrials.gov

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