Ovarian CancerPhase 2EWOC-1NCT02001272
EWOC-1 Trial: Carboplatin +/- Paclitaxel in Vulnerable Elderly Patients With Stage III-IV Advanced Ovarian Cancer
A Phase 2 study testing Paclitaxel + Carboplatin every 3 weeks, Carboplatin monotherapy every 3 weeks and Weekly Paclitaxel and Carboplatin in people with Ovarian Cancer, run by Hospices Civils de Lyon at 63 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Paclitaxel + Carboplatin every 3 weeks, Carboplatin monotherapy every 3 weeks and Weekly Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 63 sitesin 6 countries
- Study dates
- Dec 2013to Feb 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
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- Life expectancy > 3 months.
- Written informed consent obtained.
- Covered by a Health System where applicable
Who cannot join
- 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
Trial locations and contacts
63 sites in 6 countries.
63 sites in 6 countries
France53 sites
Service d'Oncologie Médicale - Centre Hospitalier d'Alès
Alès, 30100
Service d'Oncologie Médicale - ICO Paul Papin
Angers, 49100
Service de cancérologie clinique - Institut Sainte-Catherine
Avignon, 84918
Servide d'Oncologie Médicale - Hôpital Jean Minjoz
Besançon, 25030
Service d'Oncologie Médicale - Institut Bergonié
Bordeaux, 33076
Service d'Onco-Hématologie - Hôpital Fleyriat
Bourg-en-Bresse, 01012
Service de Radiothérapie et Oncologie Médicale - Hôpital Morvan
Brest, 29200
Service d'Uro-Gynécologie - Centre François Baclesse
Caen, 14076
Service d'Oncologie - Centre Hospitalier de Chambéry
Chambéry, 73011
Service d'Oncologie Médicale - Centre Hospitalier de Cholet
Cholet, 49300
Servide d'Oncologie Médicale - Centre Jean Perrin
Clermont-Ferrand, 63000
Service d'Oncologie - Centre Hospitalier Alpes Leman
Contamines Sur Arve, 74130
Service d'Oncologie Radiothérapie - Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Service d'Oncologie Médicale - Centre d'Oncologie et de Radiothérapie du Parc
Dijon, 21000
Service d'Oncologie Médicale - Centre Georges François Leclerc
Dijon, 21079
Service de Médecine Gériatrique - Centre Hospitalier Intercommunal des Alpes du Sud -Site de Gap
Gap, 05000
Service d'Oncologie Médicale - Hôpital Michallon - CHU Grenoble
Grenoble, 38043
Service d''Hématologie Oncologie - Hôpital André Mignot
Le Chesnay, 78157
Service d'Oncologie Médicale - Centre Jean Bernard - Clinique Victor Hugo
Le Mans, 72000
Service de Médecine Interne et Oncologie Médicale - CH du Mans
Le Mans, 72000
Service d'Oncologie - Hôpital Dupuytren
Limoges, 87042
Service d'Oncologie Service 2 B Nord - Centre Léon Bérard
Lyon, 69373
Service d'Oncologie Médicale - Institut Paoli Calmettes
Marseille, 13273
Service d'Oncologie multidisciplinaire - Hôpital Nord
Marseille, 13915
Service d'Oncologie Médicale - Institut Régional du Cancer Montpellier, Val d'Aurelle
Montpellier, 34298
Service d'Oncologie Médicale - Centre Azuréen de Cancérologie
Mougins, 06250
Service de Chimiothérapie - Centre Catherine de Sienne
Nantes, 44202
Service d'Onco-Hématologie - Centre Antoine Lacassagne
Nice, 06186
Service d'Oncologie Radiothérapie - Clinique de Valdegour
Nîmes, 30900
Servicde d'Oncologie Médicale - Centre Hospitalier Régional d'Orléans
Orléans, 45067
Service d'Oncologie Médicale - Hôpital des Diaconesses
Paris, 75012
Service d'Oncologie - Hôpital Cochin
Paris, 75014
Service d'Oncologie - Groupe Hospitalier Saint-Joseph
Paris, 75674
Service d'Oncologie Médicale - Hôpital Européen Georges Pompidou
Paris, 75908
Service d'Oncologie Médicale - Centre Hospitalier de Perpignan
Perpignan, 66046
Service oncogériatrie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69495
Centre CARIO - Hôpital Privé des Côtes d'Armor
Plerin Sur Mer, 22190
Servide d'Oncologie Médicale - Centre Hospitalier de la Région d'Annecy
Pringy, 74374
Servide de Radiothérapie et Oncologie Médicale - Centre Hospitalier Intercommunal de Cornouaille
Quimper, 29107
Servide d'Oncologie Médicale - Institut Jean Godinot
Reims, 51056
Service d'Oncologie Médicale - Centre Hospitalier Yves le Foll
Saint-Brieuc, 22015
Service d'Oncologie Radiothérapie - Centre Hospitalier Privé de Saint-Grégoire
Saint-Grégoire, 35760
Service d'Oncologie Médicale - ICO Centre René Gauducheau
Saint-Herblain, 44805
Service de Médecine interne et oncologie - Hôpital Inter Armées de Begin
Saint-Mandé, 94163
Service d'Oncologie Médicale - Clinique Mutualiste de l'Estuaire, Cité Sanitaire
Saint-Nazaire, 44600
Service d'Oncologie Médicale - Groupe Hospitalier Public du Sud de l'Oise - Site de Senlis
Senlis, 60309
Service d'Oncologie Médicale - Centre Hospitalier de Sens
Sens, 89108
service d'Oncologie Médicale - Centre Hospitalier Broussais
St-Malo, 35403
Service d'Oncologie Médicale - Centre Paul Strauss
Strasbourg, 67065
Service de Chirurgie et Oncologie Gynécologique et Mammaire - Hôpitaux du Léman
Thonon-les-Bains, 74203
Service d'Oncologie Médicale - Institut Claudius Regaud
Toulouse, 31300
Service d'Oncologie Médicale - Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Service de Médecine Oncologique - Institut de Cancérologie Gustave Roussy
Villejuif, 94800
Italy6 sites
Centro di Riferimento Oncologico - CRO,IRCCS
Aviano
Azienda Ulss 21 Legnago
Legnago
Fondazione IRCCS Istituto Nazionale Tumori
Milan
Ulls13 - Mirano
Mirano
Ospedale Nuovo di Sassuolo
Sassuolo
Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo
Torino
About this study
Official title: EWOC-1 Trial: Multicenter, Randomized Trial of Carboplatin +/- Paclitaxel in Vulnerable Elderly Patients With Stage III-IV Advanced Ovarian Cancer
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.
Read more
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
- Being tested
- Paclitaxel + Carboplatin every 3 weeks, Carboplatin monotherapy every 3 weeks, Weekly Paclitaxel and Carboplatin
- Keywords
- Elderly, Vulnerable, Ovarian cancer, Chemotherapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel + Carboplatin every 3 weeksDrug
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 weeksDrug
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 CarboplatinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Drug: Weekly Paclitaxel and Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 6 courses of chemotherapy i.e 4.5 to 6 months (depending on the arm)
Secondary outcomes (6)
Therapeutical strategy
Therapeutical strategy will be assessed by measuring the feasibility of performing an optimal surgery and feasibility of performing neoadjuvant chemotherapy and surgery and post operative chemotherapy until 6 courses in case of planned interval debulking surgery.
Measured: At the end of treatment (6 courses ), i.e 4.5 to 6 months (depending on the arm)
Overall Survival
Overall survival is defined as the time period from the date of randomization to the date of death.
Measured: 2.5 years
Progression-free survival
Progression-free survival is defined as the time period from the date of randomization to the date of disease progression or death whichever occurs first.
Measured: 2.5 years
Quality of Life
Quality of life is evaluated using the FACT-O questionnaire
Measured: At the end of treatment (6 courses ), i.e 4.5 to 6 months (depending on the arm)
Safety and tolerability
Adverse events are defined using the NCI-CTC AE scale version 4.3
Measured: At the end of treatment (6 courses ), i.e 4.5 to 6 months (depending on the arm)
Aging biomarkers
Aging biomarkers are represented by the expression level of cathelin-related antimicrobial peptide or CRAMP, stathmin, EF-1α, and chitinase
Measured: At the end of treatment (6 courses ), i.e 4.5 to 6 months (depending on the arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire FALANDRY, MD, Principal investigator, Service d'oncogériatrie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001272
- Sponsor's protocol ID
- 2012-772
- Acronym
- EWOC-1
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2013
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33885718Falandry 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.
PubMed 36098291
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EWOC-1 Trial: Multicenter, Randomized Trial of Carboplatin +/- Paclitaxel in Vulnerable Elderly Patients With Stage III-IV Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02001272
- Acronym / sponsor ID
- EWOC-1 / 2012-772
- Conditions
- Ovarian Cancer
- Keywords
- Elderly, Vulnerable, Ovarian cancer, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A:Paclitaxel + Carboplatin every 3 weeks | Experimental | Drug: Paclitaxel + Carboplatin every 3 weeksPatients 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). |
| B:Carboplatin monotherapy every 3 weeks | Experimental | Drug: Carboplatin monotherapy every 3 weeksPatients randomized to the arm B receive 6 courses the following regimen: Carboplatin monotherapy AUC 5 or 6 every 3 weeks (1 cycle = 21 days). |
| C:Weekly Paclitaxel and Carboplatin | Experimental | Drug: Weekly Paclitaxel and CarboplatinPatients 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). |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel + Carboplatin every 3 weeksPatients 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. | Drug | A:Paclitaxel + Carboplatin every 3 weeks |
| Carboplatin monotherapy every 3 weeksA 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. | Drug | B:Carboplatin monotherapy every 3 weeks |
| Weekly Paclitaxel and CarboplatinA 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. | Drug | C:Weekly Paclitaxel and Carboplatin |
Primary outcome
Treatment success.Treatment success is defined as the ability to deliver 6 courses of chemotherapy without premature termination for progression, death or unacceptable toxicity
Time frame: After 6 courses of chemotherapy i.e 4.5 to 6 months (depending on the arm)
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.
6 secondary outcomes
Therapeutical strategy
Time frame: At the end of treatment (6 courses ), i.e 4.5 to 6 months (depending on the arm)
Overall Survival
Time frame: 2.5 years
Progression-free survival
Time frame: 2.5 years
Quality of Life
Time frame: At the end of treatment (6 courses ), i.e 4.5 to 6 months (depending on the arm)
Safety and tolerability
Time frame: At the end of treatment (6 courses ), i.e 4.5 to 6 months (depending on the arm)
Aging biomarkers
Time frame: At the end of treatment (6 courses ), i.e 4.5 to 6 months (depending on the arm)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 33885718Falandry 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.
- Results publication: PubMed 36098291Falandry 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 InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire FALANDRY, MD principal investigator
Service d'oncogériatrie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
63 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel + Carboplatin every 3 weeks, Carboplatin monotherapy every 3 weeks and Weekly Paclitaxel and Carboplatin in people with Ovarian Cancer, run by Hospices Civils de Lyon at 63 sites in 6 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in France, Italy, Canada, Denmark, Finland and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success.Treatment success is defined as the ability to deliver 6 courses of chemotherapy without premature termination for progression, death or unacceptable toxicity (time frame: After 6 courses of chemotherapy i.e 4.5 to 6 months (depending on the arm)). 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 NCT02001272, which also lists 2 linked publications.
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 19 Dec 2025.