EWOC-1 Trial: Carboplatin +/- Paclitaxel in Vulnerable Elderly Patients With Stage III-IV Advanced Ovarian Cancer
NCT ID: NCT02001272
Last Updated: 2025-12-19
Study Results
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Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2013-12-31
2020-02-29
Brief Summary
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To date, there is no randomized trial which could give us some evidence of how to select patients who could benefit most of one or the other regimen described above. The 4th Ovarian Cancer Consensus Conference has indeed recognised the medical unmet need of adapted therapy for elderly patients with ovarian cancer and the necessity of additional research in this population.
Recently, GINECO has described a Geriatric Vulnerability Score (GVS) in a population of elderly patients with advanced ovarian cancer included in a specific multicenter phase II trial. The best proportional hazard model fitting for overall survival identified the following geriatric covariates score as being poor survival risk factors: ADL score \<6, IADL score \<25, HADS score \>14, albuminemia \<35g/L and , lymphopenia \<1G/L. GVS is the sum of these risk factors for each patient. Using a cut off of 3, the GVS identified a group of patients at high risk of severe toxicity, early cessation of treatment, unplanned hospitalization and adverse outcomes.
This international multicentre randomized phase II trial will compare the success rate of delivering 6 courses of chemotherapy with evidence of efficacy and without premature termination for progression, death or unacceptable toxicity of three different chemotherapy regimens in a selected population of elderly patients with a GVS ≥ 3:
* Arm A: Paclitaxel 175mg/m²/3 hours, I.V. and carboplatin AUC 5, I.V. every 3 weeks
* Arm B: Carboplatin monotherapy AUC 5 or 6 every 3 weeks
* Arm C: Weekly paclitaxel 60 mg/m²/1 hour and weekly carboplatin AUC 2 (d1, d8, d15 every 4 weeks)
The total number of patients to be enrolled is 240, ie 22 in each arm (total = 66) at the first step, then 58 more by arm (total=174) after interim analysis.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A:Paclitaxel + Carboplatin every 3 weeks
Patients randomized to the arm A receive 6 courses the following regimen: Paclitaxel 175 mg/m²/3 hours, I.V. and carboplatin AUC 5, I.V. every 3 weeks (1 cycle = 21 days).
Paclitaxel + Carboplatin every 3 weeks
Patients will receive a premedication of 130mg prednisolone the day before (22 pm) and the morning (7 am). A pretreatment using corticosteroids, antihistamines and H2 antagonists and setrons in accordance with local standards of care will be administered 30 minutes before Paclitaxel administration. At H0, Paclitaxel is administered at 175mg/m² in 3 hours then Carboplatin is administered at AUC 5mg/mL/min.
B:Carboplatin monotherapy every 3 weeks
Patients randomized to the arm B receive 6 courses the following regimen: Carboplatin monotherapy AUC 5 or 6 every 3 weeks (1 cycle = 21 days).
Carboplatin monotherapy every 3 weeks
A pretreatment using setrons in accordance with local standards of care will be administered 30 minutes before Carboplatin at AUC 5 to 6mg/mL/min in 1 hour.
C:Weekly Paclitaxel and Carboplatin
Patients randomized to the arm C receive 6 courses the following regimen: weekly paclitaxel 60 mg/m²/1 hour and weekly carboplatin AUC 2 (d1, d8, d15 ; d1=d29) (1 cycle = 28 days).
Weekly Paclitaxel and Carboplatin
A pretreatment using corticosteroids, antihistamines and H2 antagonists and setrons in accordance with local standards of care will be administered 30 minutes before Paclitaxel 60mg/m² in 1 hour followed by Carboplatin at AUC 2mg/mL/min in 1 hour.
Interventions
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Paclitaxel + Carboplatin every 3 weeks
Patients will receive a premedication of 130mg prednisolone the day before (22 pm) and the morning (7 am). A pretreatment using corticosteroids, antihistamines and H2 antagonists and setrons in accordance with local standards of care will be administered 30 minutes before Paclitaxel administration. At H0, Paclitaxel is administered at 175mg/m² in 3 hours then Carboplatin is administered at AUC 5mg/mL/min.
Carboplatin monotherapy every 3 weeks
A pretreatment using setrons in accordance with local standards of care will be administered 30 minutes before Carboplatin at AUC 5 to 6mg/mL/min in 1 hour.
Weekly Paclitaxel and Carboplatin
A pretreatment using corticosteroids, antihistamines and H2 antagonists and setrons in accordance with local standards of care will be administered 30 minutes before Paclitaxel 60mg/m² in 1 hour followed by Carboplatin at AUC 2mg/mL/min in 1 hour.
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically proven FIGO stage III to IV epithelial ovarian cancer or peritoneal primary or fallopian tube. A cytological proof is accepted if associated with a ratio of CA125/CEA \>25 and a radiological pelvic mass.
* GVS (Geriatric Vulnerability Score) \>3.
* Adequate bone marrow function including the following: Neutrophils ≥ 1.5 x 109/L , platelets ≥100 x 109/L and hemoglobin ≥9 g/dL.
* Adequate glomerular filtration rate \>40 ml/min (estimates based on MDRD or Chatelut formula are sufficient)
* No icterus.
* Life expectancy \> 3 months.
* Written informed consent obtained.
* Covered by a Health System where applicable
Exclusion Criteria
* Prior history of chemotherapy.
* Prior history of radiotherapy which may affect patient tolerability to chemotherapy.
* Major perturbations of liver biology: Bilirubin \> 2 fold the upper normal limit (UNL), SGOT-SGPT \> 3 fold UNL.
* Patient unable to be regularly followed for any reason (geographic, familial, social, psychologic).
* Any mental or physical handicap at risk of interfering with the appropriate treatment.
* Known allergy to Cremophor ® EL -containing drugs.
* Any administrative or legal supervision where applicable
70 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Claire FALANDRY, MD
Role: PRINCIPAL_INVESTIGATOR
Service d'oncogériatrie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Locations
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Notre-Dame Hospital of the CHUM
Montreal, , Canada
Herlev Hospital
Herlev, , Denmark
Kuopio University Hospital
Kuopio, , Finland
Service d'Oncologie Médicale - Centre Hospitalier d'Alès
Alès, , France
Service d'Oncologie Médicale - ICO Paul Papin
Angers, , France
Service de cancérologie clinique - Institut Sainte-Catherine
Avignon, , France
Servide d'Oncologie Médicale - Hôpital Jean Minjoz
Besançon, , France
Service d'Oncologie Médicale - Institut Bergonié
Bordeaux, , France
Service d'Onco-Hématologie - Hôpital Fleyriat
Bourg-en-Bresse, , France
Service de Radiothérapie et Oncologie Médicale - Hôpital Morvan
Brest, , France
Service d'Uro-Gynécologie - Centre François Baclesse
Caen, , France
Service d'Oncologie - Centre Hospitalier de Chambéry
Chambéry, , France
Service d'Oncologie Médicale - Centre Hospitalier de Cholet
Cholet, , France
Servide d'Oncologie Médicale - Centre Jean Perrin
Clermont-Ferrand, , France
Service d'Oncologie - Centre Hospitalier Alpes Leman
Contamines Sur Arve, , France
Service d'Oncologie Radiothérapie - Centre Hospitalier Intercommunal de Créteil
Créteil, , France
Service d'Oncologie Médicale - Centre d'Oncologie et de Radiothérapie du Parc
Dijon, , France
Service d'Oncologie Médicale - Centre Georges François Leclerc
Dijon, , France
Service de Médecine Gériatrique - Centre Hospitalier Intercommunal des Alpes du Sud -Site de Gap
Gap, , France
Service d'Oncologie Médicale - Hôpital Michallon - CHU Grenoble
Grenoble, , France
Service d''Hématologie Oncologie - Hôpital André Mignot
Le Chesnay, , France
Service d'Oncologie Médicale - Centre Jean Bernard - Clinique Victor Hugo
Le Mans, , France
Service de Médecine Interne et Oncologie Médicale - CH du Mans
Le Mans, , France
Service d'Oncologie - Hôpital Dupuytren
Limoges, , France
Service d'Oncologie Service 2 B Nord - Centre Léon Bérard
Lyon, , France
Service d'Oncologie Médicale - Institut Paoli Calmettes
Marseille, , France
Service d'Oncologie multidisciplinaire - Hôpital Nord
Marseille, , France
Service d'Oncologie Médicale - Institut Régional du Cancer Montpellier, Val d'Aurelle
Montpellier, , France
Service d'Oncologie Médicale - Centre Azuréen de Cancérologie
Mougins, , France
Service de Chimiothérapie - Centre Catherine de Sienne
Nantes, , France
Service d'Onco-Hématologie - Centre Antoine Lacassagne
Nice, , France
Service d'Oncologie Radiothérapie - Clinique de Valdegour
Nîmes, , France
Servicde d'Oncologie Médicale - Centre Hospitalier Régional d'Orléans
Orléans, , France
Service d'Oncologie Médicale - Hôpital des Diaconesses
Paris, , France
Service d'Oncologie - Hôpital Cochin
Paris, , France
Service d'Oncologie - Groupe Hospitalier Saint-Joseph
Paris, , France
Service d'Oncologie Médicale - Hôpital Européen Georges Pompidou
Paris, , France
Service d'Oncologie Médicale - Centre Hospitalier de Perpignan
Perpignan, , France
Service oncogériatrie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, , France
Centre CARIO - Hôpital Privé des Côtes d'Armor
Plerin Sur Mer, , France
Servide d'Oncologie Médicale - Centre Hospitalier de la Région d'Annecy
Pringy, , France
Servide de Radiothérapie et Oncologie Médicale - Centre Hospitalier Intercommunal de Cornouaille
Quimper, , France
Servide d'Oncologie Médicale - Institut Jean Godinot
Reims, , France
Service d'Oncologie Médicale - Centre Hospitalier Yves le Foll
Saint-Brieuc, , France
Service d'Oncologie Radiothérapie - Centre Hospitalier Privé de Saint-Grégoire
Saint-Grégoire, , France
Service d'Oncologie Médicale - ICO Centre René Gauducheau
Saint-Herblain, , France
Service de Médecine interne et oncologie - Hôpital Inter Armées de Begin
Saint-Mandé, , France
Service d'Oncologie Médicale - Clinique Mutualiste de l'Estuaire, Cité Sanitaire
Saint-Nazaire, , France
Service d'Oncologie Médicale - Groupe Hospitalier Public du Sud de l'Oise - Site de Senlis
Senlis, , France
Service d'Oncologie Médicale - Centre Hospitalier de Sens
Sens, , France
service d'Oncologie Médicale - Centre Hospitalier Broussais
St-Malo, , France
Service d'Oncologie Médicale - Centre Paul Strauss
Strasbourg, , France
Service de Chirurgie et Oncologie Gynécologique et Mammaire - Hôpitaux du Léman
Thonon-les-Bains, , France
Service d'Oncologie Médicale - Institut Claudius Regaud
Toulouse, , France
Service d'Oncologie Médicale - Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Service de Médecine Oncologique - Institut de Cancérologie Gustave Roussy
Villejuif, , France
Centro di Riferimento Oncologico - CRO,IRCCS
Aviano, , Italy
Azienda Ulss 21 Legnago
Legnago, , Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milan, , Italy
Ulls13 - Mirano
Mirano, , Italy
Ospedale Nuovo di Sassuolo
Sassuolo, , Italy
Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo
Torino, , Italy
Linköping University Hospital
Linköping, , Sweden
Countries
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References
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Falandry C, Rousseau F, Mouret-Reynier MA, Tinquaut F, Lorusso D, Herrstedt J, Savoye AM, Stefani L, Bourbouloux E, Sverdlin R, D'Hondt V, Lortholary A, Brachet PE, Zannetti A, Malaurie E, Venat-Bouvet L, Tredan O, Mourey L, Pujade-Lauraine E, Freyer G; Groupe d'Investigateurs Nationaux pour l'Etude des Cancers de l'Ovaire et du sein (GINECO). Efficacy and Safety of First-line Single-Agent Carboplatin vs Carboplatin Plus Paclitaxel for Vulnerable Older Adult Women With Ovarian Cancer: A GINECO/GCIG Randomized Clinical Trial. JAMA Oncol. 2021 Jun 1;7(6):853-861. doi: 10.1001/jamaoncol.2021.0696.
Falandry C, Pommeret F, Gladieff L, Tinquaut F, Lorusso D, Mouret-Reynier MA, D'Hondt V, Mollon-Grange D, Floquet A, Abadie-Lacourtoisie S, Brachet PE, Stefani L, Rousseau F, Frenel JS, Del Piano F, Komulainen M, Warkus T, Tredan O, Pujade-Lauraine E, Freyer G. Validation of the geriatric vulnerability score in older patients with ovarian cancer: an analysis from the GCIG-ENGOT-GINECO EWOC-1 study. Lancet Healthy Longev. 2022 Mar;3(3):e176-e185. doi: 10.1016/S2666-7568(22)00002-2. Epub 2022 Feb 4.
Related Links
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Related Info
Related Info
Other Identifiers
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2012-772
Identifier Type: -
Identifier Source: org_study_id