AzTrials
AzTrials

Ovarian CancerPhase 3SALVOVARNCT06476184

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 Phase 3 study testing Carboplatin and Paclitaxel in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 76 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Carboplatin and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
76 sitesin 4 countries
Study dates
30 Jul 2024to Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 32Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

76 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Marine COGNAT contact

+33 1 84 85 20 20

salvovar.trial@arcagy.org

76 sites in 4 countries

France50 sites, 50 recruiting

  • ICO Paul Papin

    Angers, 49055

    Sophie ABADIE-LACOURTOISIE

    Recruiting

  • CH d'Avignon

    Avignon, 84902

    Nathan AOUIZERAT

    Recruiting

  • Sainte-Catherine Institut du Cancer Avignon-Provence

    Avignon, 84918

    Julien GRENIER

    Recruiting

  • Hôpital de la Côte Basque

    Bayonne, 64100

    Thomas GRELLETY

    Recruiting

  • CHRU Besançon - Hôpital Jean Minjoz

    Besançon, 25030

    Laura MANSI

    Recruiting

  • Institut Bergonié

    Bordeaux, 33076

    Coriolan LEBRETON

    Recruiting

  • CHU de BREST - Hôpital Cavale Blanche

    Brest, 29200

    Laura DEIANA

    Recruiting

  • Centre François Baclesse

    Caen, 14076

    Florence JOLY

    Recruiting

  • Centre d'Oncologie et de Radiothérapie 37 (ROC37)

    Chambray-lès-Tours, 37170

    Pierre COMBE

    Recruiting

  • Centre Hospitalier de Cholet

    Cholet, 49300

    Sylvère GUILLEMOIS

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

    Laure VACHER

    Recruiting

  • Centre Hospitalier Alpes Leman

    Contamine-sur-Arve, 74130

    Mansour RASTKHAH

    Not yet recruiting

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94010

    Zineb SELLAM-CHORFI

    Recruiting

  • Centre Georges François Leclerc

    Dijon, 21079

    Jean-David FUMET

    Recruiting

  • CHU de Dijon

    Dijon, 21079

    Marie CHAIX

    Recruiting

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble, 38028

    Elise BONNET

    Recruiting

  • Hôpital André Mignot

    Le Chesnay, 78157

    Marie-Sophie THIS

    Recruiting

  • CHRU de Lille

    Lille, 59000

    Yohan KERBAGE

    Not yet recruiting

  • Centre Oscar Lambret

    Lille, 59020

    Stéphanie BECOURT

    Recruiting

  • CHU de Limoges - Hôpital Dupuytren

    Limoges, 87042

    Laurence VENAT-BOUVET

    Recruiting

  • Hôpital de la Croix Rousse

    Lyon, 69229

    Sophie DUPLOMB

    Not yet recruiting

  • Centre Léon Bérard

    Lyon, 69373

    Philippe TOUSSAINT

    Recruiting

  • Hôpital Privé Jean Mermoz

    Lyon, 69373

    Olfa DERBEL MILED

    Recruiting

  • Hôpital de la Timone

    Marseille, 13005

    Marie MEURER

    Not yet recruiting

  • CHRU de Montpellier - Hôpital Saint-Eloi

    Montpellier, 34059

    Clothilde LINDET-BOURGEOIS

    Recruiting

  • ICM Val d'Aurelle

    Montpellier, 34298

    Stanislas QUESADA

    Recruiting

  • Centre Azuréen de Cancérologie

    Mougins, 06250

    Rémy LARGILLIER

    Recruiting

  • Hôpital Privé du Confluent

    Nantes, 44202

    Cyriac BLONZ

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Philippe FOLLANA

    Recruiting

  • Institut de Cancérologie du Gard - CHU de Nîmes

    Nîmes, 30029

    Frédéric FITENI

    Recruiting

  • Groupe Hospitalier Diaconesses - Croix Saint-Simon

    Paris, 75012

    Frédéric SELLE

    Recruiting

  • Hôpital Cochin

    Paris, 75014

    Sixtine DE PERCIN

    Recruiting

  • Hôpital Européen George Pompidou

    Paris, 75015

    Claire GERVAIS

    Recruiting

  • Institut Curie

    Paris, 75248

    Manuel RODRIGUES

    Recruiting

  • Centre Hospitalier Général de Pau

    Pau, 64046

    Kevin BOURCIER

    Recruiting

  • HCL - Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

    Benoit YOU

    Recruiting

  • Hôpital de Poissy-Saint-Germain-en-Laye

    Poissy, 78303

    Gabriela TOSSEN

    Not yet recruiting

  • Institut Jean Godinot

    Reims, 51056

    Recruiting

  • Centre Eugène Marquis

    Rennes, 35042

    Thibault DE LA MOTTE ROUGE

    Recruiting

  • Hôpital Privé de la Loire

    Saint-Etienne, 42100

    Romain RIVOIRARD

    Not yet recruiting

  • Institut de Cancérologie de l'Ouest - ICO

    Saint-Herblain, 44805

    Dominique BERTON

    Recruiting

  • CHU Saint-Etienne - Pôle de Cancérologie

    Saint-Priest-en-Jarez, 42271

    Pauline CORBAUX

    Recruiting

  • ICANS - Institut de cancérologie Strasbourg Europe

    Strasbourg, 67033

    Lauriane EBERST

    Recruiting

  • CHU Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67098

    Lauriane EBERST

    Recruiting

  • Hôpital Foch

    Suresnes, 92151

    Asmahane BENMAZIANE

    Recruiting

  • Hôpitaux du Léman - site Thonon-les-Bains

    Thonon-les-Bains, 74203

    Fanny POMMERET

    Not yet recruiting

  • Oncopole Claudius Régaud - IUCT Oncopole

    Toulouse, 31059

    Gwénaël FERRON

    Recruiting

  • Clinique Pasteur

    Toulouse, 31300

    Mathilde MARTINEZ

    Recruiting

  • Centre Hospitalier de Valence

    Valence, 26953

    Rim BATTI

    Recruiting

  • Gustave Roussy

    Villejuif, 94805

    Alexandra LEARY

    Recruiting

Other trials in France

Japan16 sites, 16 recruiting

  • The University of Tokyo Hospital

    Bunkyō City

    Mayuyo MORI

    Not yet recruiting

  • Fukushima Medical University Hospital

    Fukushima

    Shu SOEDA

    Recruiting

  • Saitama Medical University International Medical Center

    Hidaka

    Akira YABUNO

    Recruiting

  • Hirosaki University Hospital

    Hirosaki

    Yoshihito YOKOYAMA

    Not yet recruiting

  • The Jikei University Kashiwa Hospital

    Kashiwa

    Kunihiro TAKANO

    Recruiting

  • St. Marianna University Hospital

    Kawasaki

    Nao SUZUKI

    Recruiting

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya

    Hamada Yoshinobu

    Not yet recruiting

  • Kurume University Hospital

    Kurume

    Shin NISHIO

    Not yet recruiting

  • Nagoya University Hospital

    Nagoya

    Nobuhisa YOSHIKAWA

    Recruiting

  • Kindai University Hospital

    Sayama

    Hidekatsu NAKAI

    Recruiting

  • Tohoku University Hospital

    Sendai

    Shogo SHIGETA

    Recruiting

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki

    Masahide OHMICHI

    Not yet recruiting

  • The Cancer Institute Hospital Of JFCR

    Tokyo

    Hiroyuki KANAO

    Not yet recruiting

  • The Jikei University Daisan Hospital

    Tokyo

    Kyosuke YAMOTO

    Not yet recruiting

  • The Jikei University Hospital

    Tokyo

    Aikou OKAMOTO

    Recruiting

  • The Jikei University Katsushika Medical Center

    Tokyo

    Motoaki SAITO

    Not yet recruiting

Other trials in Japan

Italy6 sites, 6 recruiting

  • Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria

    Alessandria, 15121

    Giulia Gallizzi

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

    Bologna, 40138

    Claudio Zamagni

    Recruiting

  • Careggi University Hospital

    Florence, 50134

    Maria Cristina Petrella

    Not yet recruiting

  • Alessandro Manzoni Hospital

    Lecco, 23900

    Federica Villa

    Not yet recruiting

  • Istituto Europeo Di Oncologia S.r.l.

    Milan, 20141

    Gabriella Maria Parma

    Recruiting

  • Azienda Ulss 3 Serenissima

    Venice, 30174

    Alessandra Baldoni

    Not yet recruiting

Other trials in Italy

Netherlands4 sites, 4 recruiting

  • Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

    Amsterdam, 1066 CX

    Willemien VAN DRIEL

    Not yet recruiting

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZA

    Judith KROEP

    Not yet recruiting

  • Radboud University Medical Center

    Nijmegen, 6525 GA

    Petronella OTTEVANGER

    Not yet recruiting

  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

    Rotterdam, 3015 GJ

    Ingrid BOERE

    Not yet recruiting

Other trials in Netherlands

About this study

Official title: 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

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.

Read the detailed description

SALVOVAR is 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 same standard regimen as given during neo-adjuvant period. The randomization will be stratified on the main clinical prognostic factors assumed to impact the efficacy of the assessed arms and the overall survival:

  1. Bevacizumab: planned administration: Yes, vs No
  2. BRCA mutation: planned administration: Yes, vs No/Unknown
  3. KELIMTM strate within unfavorable KELIM subgroup: very unfavorable < 0.7, vs moderately unfavorable [0.7-1.0[

The trial will be pragmatic, as it aims at confirming the superiority of the adjusted chemotherapy compared to the continuation of the standard chemotherapy in routine clinical practice, in a population of ovarian cancer patients close to the real-life clinical activity with few selection criteria.

Conditions
Ovarian Cancer
Being tested
Carboplatin, Paclitaxel
Keywords
chemotherapy, poor prognostic, unfavorable primary chemosensitivity, incomplete debulking surgery, KELIM
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    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

  • PaclitaxelDrug

    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 groups in NCT06476184
Study groupRoleWhat they receive
Experimental armExperimentalDensification 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 +/- combined with daily sub-cutaneous administrations of GCSF 30 MUI days 3 to 5, \& 10 to 12, \& 17 to 19 (at investigator discretion, as per standard of care).
Receives: Drug: Carboplatin; Drug: Paclitaxel
StandardActive comparatorContinuation of the same 3-weekly carboplatin-paclitaxel, as administered during the neo-adjuvant chemotherapy +/- combined with peg-GCSF or GCSF daily sub-cutaneous administrations, at investigator discretion, as per standard of care.
Receives: Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients operated with late complete debulking surgery

    To demonstrate the superiority in terms of efficacy of a densification of the chemotherapy with the salvage weekly dose-dense carboplatin-paclitaxel regimen compared to the continuation of the standard 3-weekly carboplatin-paclitaxel, in ovarian cancer patients found to have a poor prognostic disease (characterized by a poor chemosensitivity, with an unfavorable KELIMTM score < 1.0, and a disease not amenable to complete interval debulking surgery) after 3 cycles of standard neo-adjuvant chemotherapy.

    Measured: From the date of randomization until patients operated with late complete debulking surgery, assessed up 100 days

  2. Overall survival (OS)

    To demonstrate the superiority in terms of efficacy of a densification of the chemotherapy with the salvage weekly dose-dense carboplatin-paclitaxel regimen compared to the continuation of the standard 3-weekly carboplatin-paclitaxel, in ovarian cancer patients found to have a poor prognostic disease (characterized by a poor chemosensitivity, with an unfavorable KELIMTM score < 1.0, and a disease not amenable to complete interval debulking surgery) after 3 cycles of standard neo-adjuvant chemotherapy.

    Measured: From the date of randomization until death due to any cause, assessed up to 5 years

Secondary outcomes (9)

  1. Percentage of patients operated with late complete debulking surgery, regardless of the number of chemotherapy cycles received

    To compare the efficacy, in term of percentage of patients operated with late complete debulking surgery, between the salvage weekly dose-dense regimen and the standard regimen, regardless of the number of chemotherapy cycles received.

    Measured: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years

  2. Overall response rate according to RECIST V1.1 in the whole population

    To compare the efficacy of the salvage weekly dose-dense regimen with those of the standard regimen in terms of:

    • Radiological response after 3 cycles of treatment, based on the best radiological response using RECIST criteria
    • Progression-free survival

    Measured: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years

  3. Progression-free survival in the whole population

    To compare the efficacy of the salvage weekly dose-dense regimen with those of the standard regimen in terms of:

    • Radiological response after 3 cycles of treatment, based on the best radiological response using RECIST criteria

    Measured: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years

  4. Percentage of patients treated with a subsequent maintenance treatment with a PARP inhibitor (%) in the whole population

    To assess the impact of the adjustment to the salvage weekly dose-dense regimen on the rate of subsequent prescription of PARP inhibitors (since these drugs are indicated in patients with complete or partial response to platinum-based chemotherapy) in terms of survival.

    Measured: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years

  5. Progression-free survival and overall survival in these patients compared to those not treated with PARP inhibitor

    To assess the impact of the adjustment to the salvage weekly dose-dense regimen on the rate of subsequent prescription of PARP inhibitors (since these drugs are indicated in patients with complete or partial response to platinum-based chemotherapy) in terms of survival.

    Measured: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years

  6. To assess the impact of adding bevacizumab to chemotherapy (salvage or standard arm) on the efficacy outcomes In the population of patients treated with bevacizumab: - Overall response rate according to RECIST V1.1

    To assess the impact of adding bevacizumab to chemotherapy (salvage or standard arm) on the efficacy outcomes

    Measured: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years

  7. Adverse events graded according to the NCI Common Terminology Criteria Adverse Event Version 5.0

    To compare the safety profiles of the salvage weekly dose-dense chemotherapy arm with those of the standard 3-weekly carboplatin-paclitaxel with/without bevacizumab, based on the observed adverse-events

    Measured: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years

  8. To assess the impact of adding bevacizumab to chemotherapy on the efficacy outcomes In the population of patients treated with bevacizumab: - Progression-free survival & overall survival according to RECIST V1.1

    To assess the impact of adding bevacizumab to chemotherapy (salvage or standard arm) on the efficacy outcomes

    Measured: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years

  9. To assess the impact of adding bevacizumab to chemotherapy on the efficacy outcomes In the population of patients treated with bevacizumab: - Percentage of patients operated with a late complete debulking surgery (%)

    To assess the impact of adding bevacizumab to chemotherapy (salvage or standard arm) on the efficacy outcomes

    Measured: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first assessed up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start30 Jul 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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 +/- combined with daily sub-cutaneous administrations of GCSF (Granulocyte Colony-Stimulating Factor) 30 MUI days 3 to 5, \& 10 to 12, \& 17 to 19 (at investigator discretion, as per standard of care) * Standard arm: Continuation of the same 3-weekly carboplatin-paclitaxel, as administered during the neo-adjuvant chemotherapy +/- combined with peg-GCSF or GCSF daily sub-cutaneous administrations, at investigator discretion, as per standard of care. Of note, bevacizumab addition in both arms is required in countries where it is available as per standard of care, according to country health coverage policy.
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06476184
Sponsor's protocol ID
2023-508260-30-01
Other IDs
RECF-005636, 2023
Acronym
SALVOVAR
Status last verified
Aug 2026
First submitted
5 Jun 2024
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chator C, Yanaihara N, Chabaud S, Parma GM, Dima AL, Clamp A, Ferron G, Kroep JR, Leary A, Cibula D, Fiteni F, Bruchim I, Serrier H, Carroll S, Belmont AS, Peron J, You B. SALVOVAR: a pragmatic randomized phase III trial comparing the SALVage weekly dose-dense regimen to the standard 3-weekly regimen in patients with poor prognostic OVARian cancers. Ther Adv Med Oncol. 2025 Dec 23;17:17588359251396777. doi: 10.1177/17588359251396777. eCollection 2025.

    PubMed 41466844

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carboplatin and Paclitaxel in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 76 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in France, Japan, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marine COGNAT (+33 1 84 85 20 20, salvovar.trial@arcagy.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients operated with late complete debulking surgery (time frame: From the date of randomization until patients operated with late complete debulking surgery, assessed up 100 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06476184, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in