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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Percentage of patients operated with late complete debulking surgery — From the date of randomization until patients operated with late complete debulking surgery, assessed up 100 days
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. - Overall survival (OS) — From the date of randomization until death due to any cause, assessed up to 5 years
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.
Trial sites (76)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More ARCAGY/ GINECO GROUP trials in France
Other trials for the same condition
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 France