EWOC-1 Trial: Carboplatin +/- Paclitaxel in Vulnerable Elderly Patients With Stage III-IV Advanced Ovarian Cancer

NCT02001272 | Completed Phase 2 DMC

• 1 other identifier: 2012-772
• Study Type: interventional
• Target: 120
• Locations: 6 countries
• Sites: 63

Brief Summary

The current standard of first-line chemotherapy in advanced ovarian cancer is the combination of carboplatin AUC 5mg/mL/min and paclitaxel 175 mg.m-². This combination is feasible in selected elderly patients such as those included in prospective trials. These trials, however, include a minority of the elderly population. In wider selection of patients \>70 years old, the standard carboplatin-paclitaxel regimen has been shown to induce an excess of toxicity and premature treatment stopping. For elderly patients thought to be vulnerable and at high risk of toxicity with the standard 3-weekly carboplatin-paclitaxel regimen, other options are used in routine practice. One option is to delete paclitaxel and treat elderly patients with carboplatin as a single agent. An alternative is to use the carboplatin-paclitaxel regimen in a weekly schedule for both drugs such as reported by the MITO (Multicentre Italian Trial in Ovarian Cancer). 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.

Conditions

Ovarian Cancer

Keywords

Elderly; Vulnerable; Ovarian cancer; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Treatment success.Treatment success is defined as the ability to deliver 6 courses of chemotherapy without premature termination for progression, death or unacceptable toxicity

  Treatment success is defined as the ability to deliver 6 courses of chemotherapy without premature termination for progression, death or unacceptable toxicity. Unacceptable toxicity is defined as a major adverse event related to chemotherapy or treatment procedure leading either to early treatment stopping, to an unplanned hospital admission or to death or to a dose delay lasting more than 14 days or more than 2 dose reductions.

  After 6 courses of chemotherapy i.e 4.5 to 6 months (depending on the arm)

Secondary Outcomes (6)

• Therapeutical strategy

  At the end of treatment (6 courses ), i.e 4.5 to 6 months (depending on the arm)

• Overall Survival

  2.5 years

• Progression-free survival

  2.5 years

• Quality of Life

  At the end of treatment (6 courses ), i.e 4.5 to 6 months (depending on the arm)

• Safety and tolerability

  At the end of treatment (6 courses ), i.e 4.5 to 6 months (depending on the arm)

Study Arms (3)

A:Paclitaxel + Carboplatin every 3 weeks

EXPERIMENTAL

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).

Drug: Paclitaxel + Carboplatin every 3 weeks

B:Carboplatin monotherapy every 3 weeks

EXPERIMENTAL

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).

Drug: Carboplatin monotherapy every 3 weeks

C:Weekly Paclitaxel and Carboplatin

EXPERIMENTAL

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).

Drug: Weekly Paclitaxel and Carboplatin

Interventions

Weekly Paclitaxel and Carboplatin DRUG

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.

C:Weekly Paclitaxel and Carboplatin

Paclitaxel + Carboplatin every 3 weeks DRUG

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.

A:Paclitaxel + Carboplatin every 3 weeks

Carboplatin monotherapy every 3 weeks DRUG

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.

B:Carboplatin monotherapy every 3 weeks

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Woman \>70 year old
• 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

You may not qualify if:

• Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (63)

Notre-Dame Hospital of the CHUM

Montreal, Canada

Location

Herlev Hospital

Herlev, Denmark

Location

Kuopio University Hospital

Kuopio, Finland

Location

Service d'Oncologie Médicale - Centre Hospitalier d'Alès

Alès, 30100, France

Location

Service d'Oncologie Médicale - ICO Paul Papin

Angers, 49100, France

Location

Service de cancérologie clinique - Institut Sainte-Catherine

Avignon, 84918, France

Location

Servide d'Oncologie Médicale - Hôpital Jean Minjoz

Besançon, 25030, France

Location

Service d'Oncologie Médicale - Institut Bergonié

Bordeaux, 33076, France

Location

Service d'Onco-Hématologie - Hôpital Fleyriat

Bourg-en-Bresse, 01012, France

Location

Service de Radiothérapie et Oncologie Médicale - Hôpital Morvan

Brest, 29200, France

Location

Service d'Uro-Gynécologie - Centre François Baclesse

Caen, 14076, France

Location

Service d'Oncologie - Centre Hospitalier de Chambéry

Chambéry, 73011, France

Location

Service d'Oncologie Médicale - Centre Hospitalier de Cholet

Cholet, 49300, France

Location

Servide d'Oncologie Médicale - Centre Jean Perrin

Clermont-Ferrand, 63000, France

Location

Service d'Oncologie - Centre Hospitalier Alpes Leman

Contamines Sur Arve, 74130, France

Location

Service d'Oncologie Radiothérapie - Centre Hospitalier Intercommunal de Créteil

Créteil, 94010, France

Location

Service d'Oncologie Médicale - Centre d'Oncologie et de Radiothérapie du Parc

Dijon, 21000, France

Location

Service d'Oncologie Médicale - Centre Georges François Leclerc

Dijon, 21079, France

Location

Service de Médecine Gériatrique - Centre Hospitalier Intercommunal des Alpes du Sud -Site de Gap

Gap, 05000, France

Location

Service d'Oncologie Médicale - Hôpital Michallon - CHU Grenoble

Grenoble, 38043, France

Location

Service d''Hématologie Oncologie - Hôpital André Mignot

Le Chesnay, 78157, France

Location

Service d'Oncologie Médicale - Centre Jean Bernard - Clinique Victor Hugo

Le Mans, 72000, France

Location

Service de Médecine Interne et Oncologie Médicale - CH du Mans

Le Mans, 72000, France

Location

Service d'Oncologie - Hôpital Dupuytren

Limoges, 87042, France

Location

Service d'Oncologie Service 2 B Nord - Centre Léon Bérard

Lyon, 69373, France

Location

Service d'Oncologie Médicale - Institut Paoli Calmettes

Marseille, 13273, France

Location

Service d'Oncologie multidisciplinaire - Hôpital Nord

Marseille, 13915, France

Location

Service d'Oncologie Médicale - Institut Régional du Cancer Montpellier, Val d'Aurelle

Montpellier, 34298, France

Location

Service d'Oncologie Médicale - Centre Azuréen de Cancérologie

Mougins, 06250, France

Location

Service de Chimiothérapie - Centre Catherine de Sienne

Nantes, 44202, France

Location

Service d'Onco-Hématologie - Centre Antoine Lacassagne

Nice, 06186, France

Location

Service d'Oncologie Radiothérapie - Clinique de Valdegour

Nîmes, 30900, France

Location

Servicde d'Oncologie Médicale - Centre Hospitalier Régional d'Orléans

Orléans, 45067, France

Location

Service d'Oncologie Médicale - Hôpital des Diaconesses

Paris, 75012, France

Location

Service d'Oncologie - Hôpital Cochin

Paris, 75014, France

Location

Service d'Oncologie - Groupe Hospitalier Saint-Joseph

Paris, 75674, France

Location

Service d'Oncologie Médicale - Hôpital Européen Georges Pompidou

Paris, 75908, France

Location

Service d'Oncologie Médicale - Centre Hospitalier de Perpignan

Perpignan, 66046, France

Location

Service oncogériatrie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

Centre CARIO - Hôpital Privé des Côtes d'Armor

Plerin Sur Mer, 22190, France

Location

Servide d'Oncologie Médicale - Centre Hospitalier de la Région d'Annecy

Pringy, 74374, France

Location

Servide de Radiothérapie et Oncologie Médicale - Centre Hospitalier Intercommunal de Cornouaille

Quimper, 29107, France

Location

Servide d'Oncologie Médicale - Institut Jean Godinot

Reims, 51056, France

Location

Service d'Oncologie Médicale - Centre Hospitalier Yves le Foll

Saint-Brieuc, 22015, France

Location

Service d'Oncologie Radiothérapie - Centre Hospitalier Privé de Saint-Grégoire

Saint-Grégoire, 35760, France

Location

Service d'Oncologie Médicale - ICO Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Service de Médecine interne et oncologie - Hôpital Inter Armées de Begin

Saint-Mandé, 94163, France

Location

Service d'Oncologie Médicale - Clinique Mutualiste de l'Estuaire, Cité Sanitaire

Saint-Nazaire, 44600, France

Location

Service d'Oncologie Médicale - Groupe Hospitalier Public du Sud de l'Oise - Site de Senlis

Senlis, 60309, France

Location

Service d'Oncologie Médicale - Centre Hospitalier de Sens

Sens, 89108, France

Location

service d'Oncologie Médicale - Centre Hospitalier Broussais

St-Malo, 35403, France

Location

Service d'Oncologie Médicale - Centre Paul Strauss

Strasbourg, 67065, France

Location

Service de Chirurgie et Oncologie Gynécologique et Mammaire - Hôpitaux du Léman

Thonon-les-Bains, 74203, France

Location

Service d'Oncologie Médicale - Institut Claudius Regaud

Toulouse, 31300, France

Location

Service d'Oncologie Médicale - Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Service de Médecine Oncologique - Institut de Cancérologie Gustave Roussy

Villejuif, 94800, France

Location

Centro di Riferimento Oncologico - CRO,IRCCS

Aviano, Italy

Location

Azienda Ulss 21 Legnago

Legnago, Italy

Location

Fondazione IRCCS Istituto Nazionale Tumori

Milan, Italy

Location

Ulls13 - Mirano

Mirano, Italy

Location

Ospedale Nuovo di Sassuolo

Sassuolo, Italy

Location

Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo

Torino, Italy

Location

Linköping University Hospital

Linköping, Sweden

Location

Related Publications (2)

• 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.

  PMID: 33885718 RESULT

• 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.

  PMID: 36098291 RESULT

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Claire FALANDRY, MD

  Service d'oncogériatrie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: December 4, 2013
• Study Start: December 1, 2013
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

CA (1); DK (1); FI (1); IT (6); FR (53); SE (1)