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Weekly chemo boost could help ovarian cancer patients who Don't respond to standard treatment

NCT ID NCT06476184

Disease control Sponsor: ARCAGY/ GINECO GROUP Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 05, 2026 · Updated 4 times

Summary

This phase 3 trial tests whether a denser weekly chemotherapy schedule (carboplatin every 3 weeks plus weekly paclitaxel) can help ovarian cancer patients whose tumors are not responding well to standard treatment. The study enrolls 250 adults with advanced ovarian cancer who have already had 3-4 cycles of standard chemo. The goal is to see if the weekly regimen makes more patients eligible for complete tumor removal surgery and improves overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Carboplatin and paclitaxel (chemotherapy drugs)
What this could lead to
If successful, this denser weekly chemo schedule could help more patients with hard-to-treat ovarian cancer become eligible for complete tumor removal surgery, potentially extending survival.
What could go wrong
This is a mid-stage trial with 250 participants, so results are not yet proven. The weekly regimen may cause more side effects like fatigue or low blood counts, and it may not improve outcomes for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fallopian tube carcinoma ovarian adenocarcinoma ovarian cancer primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    76 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alessandro Manzoni Hospital

    NOT_YET_RECRUITING

    Lecco, 23900, Italy

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

    RECRUITING

    Bologna, 40138, Italy

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

    NOT_YET_RECRUITING

    Alessandria, 15121, Italy

  • Azienda Ulss 3 Serenissima

    NOT_YET_RECRUITING

    Venice, 30174, Italy

  • CH d'Avignon

    RECRUITING

    Avignon, 84902, France

  • CHRU Besançon - Hôpital Jean Minjoz

    RECRUITING

    Besançon, 25030, France

  • CHRU de Lille

    NOT_YET_RECRUITING

    Lille, 59000, France

  • CHRU de Montpellier - Hôpital Saint-Eloi

    RECRUITING

    Montpellier, 34059, France

  • CHU Saint-Etienne - Pôle de Cancérologie

    RECRUITING

    Saint-Priest-en-Jarez, 42271, France

  • CHU Strasbourg - Hôpital de Hautepierre

    RECRUITING

    Strasbourg, 67098, France

  • CHU de BREST - Hôpital Cavale Blanche

    RECRUITING

    Brest, 29200, France

  • CHU de Dijon

    RECRUITING

    Dijon, 21079, France

  • CHU de Limoges - Hôpital Dupuytren

    RECRUITING

    Limoges, 87042, France

  • Careggi University Hospital

    NOT_YET_RECRUITING

    Florence, 50134, Italy

  • Centre Antoine Lacassagne

    RECRUITING

    Nice, 06189, France

  • Centre Azuréen de Cancérologie

    RECRUITING

    Mougins, 06250, France

  • Centre Eugène Marquis

    RECRUITING

    Rennes, 35042, France

  • Centre François Baclesse

    RECRUITING

    Caen, 14076, France

  • Centre Georges François Leclerc

    RECRUITING

    Dijon, 21079, France

  • Centre Hospitalier Alpes Leman

    NOT_YET_RECRUITING

    Contamine-sur-Arve, 74130, France

  • Centre Hospitalier Général de Pau

    RECRUITING

    Pau, 64046, France

  • Centre Hospitalier Intercommunal de Créteil

    RECRUITING

    Créteil, 94010, France

  • Centre Hospitalier de Cholet

    RECRUITING

    Cholet, 49300, France

  • Centre Hospitalier de Valence

    RECRUITING

    Valence, 26953, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, 63011, France

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69373, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, 59020, France

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

    RECRUITING

    Chambray-lès-Tours, 37170, France

  • Clinique Pasteur

    RECRUITING

    Toulouse, 31300, France

  • Dokkyo Medical University Saitama Medical Center

    NOT_YET_RECRUITING

    Koshigaya, Japan

  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

    NOT_YET_RECRUITING

    Rotterdam, 3015 GJ, Netherlands

  • Fukushima Medical University Hospital

    RECRUITING

    Fukushima, Japan

  • Groupe Hospitalier Diaconesses - Croix Saint-Simon

    RECRUITING

    Paris, 75012, France

  • Groupe Hospitalier Mutualiste de Grenoble

    RECRUITING

    Grenoble, 38028, France

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • HCL - Centre Hospitalier Lyon Sud

    RECRUITING

    Pierre-Bénite, 69495, France

  • Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

    NOT_YET_RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • Hirosaki University Hospital

    NOT_YET_RECRUITING

    Hirosaki, Japan

  • Hôpital André Mignot

    RECRUITING

    Le Chesnay, 78157, France

  • Hôpital Cochin

    RECRUITING

    Paris, 75014, France

  • Hôpital Européen George Pompidou

    RECRUITING

    Paris, 75015, France

  • Hôpital Foch

    RECRUITING

    Suresnes, 92151, France

  • Hôpital Privé Jean Mermoz

    RECRUITING

    Lyon, 69373, France

  • Hôpital Privé de la Loire

    NOT_YET_RECRUITING

    Saint-Etienne, 42100, France

  • Hôpital Privé du Confluent

    RECRUITING

    Nantes, 44202, France

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

    NOT_YET_RECRUITING

    Poissy, 78303, France

  • Hôpital de la Croix Rousse

    NOT_YET_RECRUITING

    Lyon, 69229, France

  • Hôpital de la Côte Basque

    RECRUITING

    Bayonne, 64100, France

  • Hôpital de la Timone

    NOT_YET_RECRUITING

    Marseille, 13005, France

  • Hôpitaux du Léman - site Thonon-les-Bains

    NOT_YET_RECRUITING

    Thonon-les-Bains, 74203, France

  • ICANS - Institut de cancérologie Strasbourg Europe

    RECRUITING

    Strasbourg, 67033, France

  • ICM Val d'Aurelle

    RECRUITING

    Montpellier, 34298, France

  • ICO Paul Papin

    RECRUITING

    Angers, 49055, France

  • Institut Bergonié

    RECRUITING

    Bordeaux, 33076, France

  • Institut Curie

    RECRUITING

    Paris, 75248, France

  • Institut Jean Godinot

    RECRUITING

    Reims, 51056, France

  • Institut de Cancérologie de l'Ouest - ICO

    RECRUITING

    Saint-Herblain, 44805, France

  • Institut de Cancérologie du Gard - CHU de Nîmes

    RECRUITING

    Nîmes, 30029, France

  • Istituto Europeo Di Oncologia S.r.l.

    RECRUITING

    Milan, 20141, Italy

  • Kindai University Hospital

    RECRUITING

    Sayama, Japan

  • Kurume University Hospital

    NOT_YET_RECRUITING

    Kurume, Japan

  • Leids Universitair Medisch Centrum (LUMC)

    NOT_YET_RECRUITING

    Leiden, 2333 ZA, Netherlands

  • Nagoya University Hospital

    RECRUITING

    Nagoya, Japan

  • Oncopole Claudius Régaud - IUCT Oncopole

    RECRUITING

    Toulouse, 31059, France

  • Osaka Medical and Pharmaceutical University Hospital

    NOT_YET_RECRUITING

    Takatsuki, Japan

  • Radboud University Medical Center

    NOT_YET_RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Sainte-Catherine Institut du Cancer Avignon-Provence

    RECRUITING

    Avignon, 84918, France

  • Saitama Medical University International Medical Center

    RECRUITING

    Hidaka, Japan

  • St. Marianna University Hospital

    RECRUITING

    Kawasaki, Japan

  • The Cancer Institute Hospital Of JFCR

    NOT_YET_RECRUITING

    Tokyo, Japan

  • The Jikei University Daisan Hospital

    NOT_YET_RECRUITING

    Tokyo, Japan

  • The Jikei University Hospital

    RECRUITING

    Tokyo, Japan

  • The Jikei University Kashiwa Hospital

    RECRUITING

    Kashiwa, Japan

  • The Jikei University Katsushika Medical Center

    NOT_YET_RECRUITING

    Tokyo, Japan

  • The University of Tokyo Hospital

    NOT_YET_RECRUITING

    Bunkyō City, Japan

  • Tohoku University Hospital

    RECRUITING

    Sendai, Japan

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