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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Paclitaxel + Carboplatin every 3 weeks
Carboplatin monotherapy every 3 weeks
Weekly Paclitaxel and Carboplatin
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Elderly, Vulnerable, Ovarian cancer, Chemotherapy

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Notre-Dame Hospital of the CHUM
  • Herlev Hospital
  • Kuopio University Hospital
  • Service d'Oncologie Médicale - Centre Hospitalier d'Alès
  • Service d'Oncologie Médicale - ICO Paul Papin
  • Service de cancérologie clinique - Institut Sainte-Catherine
  • Servide d'Oncologie Médicale - Hôpital Jean Minjoz
  • Service d'Oncologie Médicale - Institut Bergonié
  • Service d'Onco-Hématologie - Hôpital Fleyriat
  • Service de Radiothérapie et Oncologie Médicale - Hôpital Morvan
  • Service d'Uro-Gynécologie - Centre François Baclesse
  • Service d'Oncologie - Centre Hospitalier de Chambéry
  • Service d'Oncologie Médicale - Centre Hospitalier de Cholet
  • Servide d'Oncologie Médicale - Centre Jean Perrin
  • Service d'Oncologie - Centre Hospitalier Alpes Leman
  • Service d'Oncologie Radiothérapie - Centre Hospitalier Intercommunal de Créteil
  • Service d'Oncologie Médicale - Centre d'Oncologie et de Radiothérapie du Parc
  • Service d'Oncologie Médicale - Centre Georges François Leclerc
  • Service de Médecine Gériatrique - Centre Hospitalier Intercommunal des Alpes du Sud -Site de Gap
  • Service d'Oncologie Médicale - Hôpital Michallon - CHU Grenoble
  • Service d''Hématologie Oncologie - Hôpital André Mignot
  • Service d'Oncologie Médicale - Centre Jean Bernard - Clinique Victor Hugo
  • Service de Médecine Interne et Oncologie Médicale - CH du Mans
  • Service d'Oncologie - Hôpital Dupuytren
  • Service d'Oncologie Service 2 B Nord - Centre Léon Bérard
  • Service d'Oncologie multidisciplinaire - Hôpital Nord
  • Service d'Oncologie Médicale - Institut Paoli Calmettes
  • Service d'Oncologie Médicale - Institut Régional du Cancer Montpellier, Val d'Aurelle
  • Service d'Oncologie Médicale - Centre Azuréen de Cancérologie
  • Service de Chimiothérapie - Centre Catherine de Sienne
  • Service d'Onco-Hématologie - Centre Antoine Lacassagne
  • Service d'Oncologie Radiothérapie - Clinique de Valdegour
  • Servicde d'Oncologie Médicale - Centre Hospitalier Régional d'Orléans
  • Service d'Oncologie Médicale - Hôpital des Diaconesses
  • Service d'Oncologie - Hôpital Cochin
  • Service d'Oncologie Médicale - Hôpital Européen Georges Pompidou
  • Service d'Oncologie - Groupe Hospitalier Saint-Joseph
  • Service d'Oncologie Médicale - Centre Hospitalier de Perpignan
  • Service oncogériatrie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
  • Centre CARIO - Hôpital Privé des Côtes d'Armor
  • Servide d'Oncologie Médicale - Centre Hospitalier de la Région d'Annecy
  • Servide de Radiothérapie et Oncologie Médicale - Centre Hospitalier Intercommunal de Cornouaille
  • Servide d'Oncologie Médicale - Institut Jean Godinot
  • Service d'Oncologie Médicale - Centre Hospitalier Yves le Foll
  • Service d'Oncologie Médicale - ICO Centre René Gauducheau
  • service d'Oncologie Médicale - Centre Hospitalier Broussais
  • Service de Médecine interne et oncologie - Hôpital Inter Armées de Begin
  • Service d'Oncologie Médicale - Clinique Mutualiste de l'Estuaire, Cité Sanitaire
  • Service d'Oncologie Radiothérapie - Centre Hospitalier Privé de Saint-Grégoire
  • Service d'Oncologie Médicale - Groupe Hospitalier Public du Sud de l'Oise - Site de Senlis
  • Service d'Oncologie Médicale - Centre Hospitalier de Sens
  • Service d'Oncologie Médicale - Centre Paul Strauss
  • Service de Chirurgie et Oncologie Gynécologique et Mammaire - Hôpitaux du Léman
  • Service d'Oncologie Médicale - Institut Claudius Regaud
  • Service d'Oncologie Médicale - Institut de Cancérologie de Lorraine
  • Service de Médecine Oncologique - Institut de Cancérologie Gustave Roussy
  • Centro di Riferimento Oncologico - CRO,IRCCS
  • Azienda Ulss 21 Legnago
  • Fondazione IRCCS Istituto Nazionale Tumori
  • Ulls13 - Mirano
  • Ospedale Nuovo di Sassuolo
  • Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo
  • Linköping University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

A:Paclitaxel + Carboplatin every 3 weeks

B:Carboplatin monotherapy every 3 weeks

C:Weekly Paclitaxel and Carboplatin

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Overall Survival
Overall survival is defined as the time period from the date of randomization to the date of death.
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.
Quality of Life
Quality of life is evaluated using the FACT-O questionnaire
Safety and tolerability
Adverse events are defined using the NCI-CTC AE scale version 4.3
Aging biomarkers
Aging biomarkers are represented by the expression level of cathelin-related antimicrobial peptide or CRAMP, stathmin, EF-1α, and chitinase

Full Information

First Posted
November 22, 2013
Last Updated
August 3, 2020
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02001272
Brief Title
EWOC-1 Trial: Carboplatin +/- Paclitaxel in Vulnerable Elderly Patients With Stage III-IV Advanced Ovarian Cancer
Acronym
EWOC-1
Official Title
EWOC-1 Trial: Multicenter, Randomized Trial of Carboplatin +/- Paclitaxel in Vulnerable Elderly Patients With Stage III-IV Advanced Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Elderly, Vulnerable, Ovarian cancer, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A:Paclitaxel + Carboplatin every 3 weeks
Arm Type
Experimental
Arm Description
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).
Arm Title
B:Carboplatin monotherapy every 3 weeks
Arm Type
Experimental
Arm Description
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).
Arm Title
C:Weekly Paclitaxel and Carboplatin
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Paclitaxel + Carboplatin every 3 weeks
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin monotherapy every 3 weeks
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Weekly Paclitaxel and Carboplatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment success.Treatment success is defined as the ability to deliver 6 courses of chemotherapy without premature termination for progression, death or unacceptable toxicity
Description
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.
Time Frame
After 6 courses of chemotherapy i.e 4.5 to 6 months (depending on the arm)
Secondary Outcome Measure Information:
Title
Therapeutical strategy
Description
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.
Time Frame
At the end of treatment (6 courses ), i.e 4.5 to 6 months (depending on the arm)
Title
Overall Survival
Description
Overall survival is defined as the time period from the date of randomization to the date of death.
Time Frame
2.5 years
Title
Progression-free survival
Description
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.
Time Frame
2.5 years
Title
Quality of Life
Description
Quality of life is evaluated using the FACT-O questionnaire
Time Frame
At the end of treatment (6 courses ), i.e 4.5 to 6 months (depending on the arm)
Title
Safety and tolerability
Description
Adverse events are defined using the NCI-CTC AE scale version 4.3
Time Frame
At the end of treatment (6 courses ), i.e 4.5 to 6 months (depending on the arm)
Title
Aging biomarkers
Description
Aging biomarkers are represented by the expression level of cathelin-related antimicrobial peptide or CRAMP, stathmin, EF-1α, and chitinase
Time Frame
At the end of treatment (6 courses ), i.e 4.5 to 6 months (depending on the arm)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire FALANDRY, MD
Organizational Affiliation
Service d'oncogériatrie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Notre-Dame Hospital of the CHUM
City
Montréal
Country
Canada
Facility Name
Herlev Hospital
City
Herlev
Country
Denmark
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Facility Name
Service d'Oncologie Médicale - Centre Hospitalier d'Alès
City
Alès
ZIP/Postal Code
30100
Country
France
Facility Name
Service d'Oncologie Médicale - ICO Paul Papin
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Service de cancérologie clinique - Institut Sainte-Catherine
City
Avignon Cedex 9
ZIP/Postal Code
84918
Country
France
Facility Name
Servide d'Oncologie Médicale - Hôpital Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Service d'Oncologie Médicale - Institut Bergonié
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Service d'Onco-Hématologie - Hôpital Fleyriat
City
Bourg en Bresse
ZIP/Postal Code
01012
Country
France
Facility Name
Service de Radiothérapie et Oncologie Médicale - Hôpital Morvan
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Service d'Uro-Gynécologie - Centre François Baclesse
City
Caen Cedex 5
ZIP/Postal Code
14076
Country
France
Facility Name
Service d'Oncologie - Centre Hospitalier de Chambéry
City
Chambéry
ZIP/Postal Code
73011
Country
France
Facility Name
Service d'Oncologie Médicale - Centre Hospitalier de Cholet
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
Servide d'Oncologie Médicale - Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Service d'Oncologie - Centre Hospitalier Alpes Leman
City
Contamines Sur Arve
ZIP/Postal Code
74130
Country
France
Facility Name
Service d'Oncologie Radiothérapie - Centre Hospitalier Intercommunal de Créteil
City
Créteil Cedex
ZIP/Postal Code
94010
Country
France
Facility Name
Service d'Oncologie Médicale - Centre d'Oncologie et de Radiothérapie du Parc
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Service d'Oncologie Médicale - Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Service de Médecine Gériatrique - Centre Hospitalier Intercommunal des Alpes du Sud -Site de Gap
City
Gap
ZIP/Postal Code
05000
Country
France
Facility Name
Service d'Oncologie Médicale - Hôpital Michallon - CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Service d''Hématologie Oncologie - Hôpital André Mignot
City
Le Chesnay Cedex
ZIP/Postal Code
78157
Country
France
Facility Name
Service d'Oncologie Médicale - Centre Jean Bernard - Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Service de Médecine Interne et Oncologie Médicale - CH du Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Service d'Oncologie - Hôpital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Service d'Oncologie Service 2 B Nord - Centre Léon Bérard
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Service d'Oncologie multidisciplinaire - Hôpital Nord
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
Service d'Oncologie Médicale - Institut Paoli Calmettes
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Facility Name
Service d'Oncologie Médicale - Institut Régional du Cancer Montpellier, Val d'Aurelle
City
Montpellier Cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
Service d'Oncologie Médicale - Centre Azuréen de Cancérologie
City
Mougins Cedex 02
ZIP/Postal Code
06250
Country
France
Facility Name
Service de Chimiothérapie - Centre Catherine de Sienne
City
Nantes Cedex 2
ZIP/Postal Code
44202
Country
France
Facility Name
Service d'Onco-Hématologie - Centre Antoine Lacassagne
City
Nice Cedex 2
ZIP/Postal Code
06186
Country
France
Facility Name
Service d'Oncologie Radiothérapie - Clinique de Valdegour
City
Nîmes
ZIP/Postal Code
30900
Country
France
Facility Name
Servicde d'Oncologie Médicale - Centre Hospitalier Régional d'Orléans
City
Orléans Cedex 02
ZIP/Postal Code
45067
Country
France
Facility Name
Service d'Oncologie Médicale - Hôpital des Diaconesses
City
Paris Cedex 12
ZIP/Postal Code
75012
Country
France
Facility Name
Service d'Oncologie - Hôpital Cochin
City
Paris Cedex 14
ZIP/Postal Code
75014
Country
France
Facility Name
Service d'Oncologie Médicale - Hôpital Européen Georges Pompidou
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
Facility Name
Service d'Oncologie - Groupe Hospitalier Saint-Joseph
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Service d'Oncologie Médicale - Centre Hospitalier de Perpignan
City
Perpignan
ZIP/Postal Code
66046
Country
France
Facility Name
Service oncogériatrie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre CARIO - Hôpital Privé des Côtes d'Armor
City
Plerin Sur Mer
ZIP/Postal Code
22190
Country
France
Facility Name
Servide d'Oncologie Médicale - Centre Hospitalier de la Région d'Annecy
City
Pringy Cedex
ZIP/Postal Code
74374
Country
France
Facility Name
Servide de Radiothérapie et Oncologie Médicale - Centre Hospitalier Intercommunal de Cornouaille
City
Quimper Cedex
ZIP/Postal Code
29107
Country
France
Facility Name
Servide d'Oncologie Médicale - Institut Jean Godinot
City
Reims Cedex
ZIP/Postal Code
51056
Country
France
Facility Name
Service d'Oncologie Médicale - Centre Hospitalier Yves le Foll
City
Saint Brieuc
ZIP/Postal Code
22015
Country
France
Facility Name
Service d'Oncologie Médicale - ICO Centre René Gauducheau
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
service d'Oncologie Médicale - Centre Hospitalier Broussais
City
Saint Malo
ZIP/Postal Code
35403
Country
France
Facility Name
Service de Médecine interne et oncologie - Hôpital Inter Armées de Begin
City
Saint Mandé
ZIP/Postal Code
94163
Country
France
Facility Name
Service d'Oncologie Médicale - Clinique Mutualiste de l'Estuaire, Cité Sanitaire
City
Saint Nazaire
ZIP/Postal Code
44600
Country
France
Facility Name
Service d'Oncologie Radiothérapie - Centre Hospitalier Privé de Saint-Grégoire
City
Saint-Grégoire
ZIP/Postal Code
35760
Country
France
Facility Name
Service d'Oncologie Médicale - Groupe Hospitalier Public du Sud de l'Oise - Site de Senlis
City
Senlis
ZIP/Postal Code
60309
Country
France
Facility Name
Service d'Oncologie Médicale - Centre Hospitalier de Sens
City
Sens
ZIP/Postal Code
89108
Country
France
Facility Name
Service d'Oncologie Médicale - Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Service de Chirurgie et Oncologie Gynécologique et Mammaire - Hôpitaux du Léman
City
Thonon les Bains
ZIP/Postal Code
74203
Country
France
Facility Name
Service d'Oncologie Médicale - Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
Service d'Oncologie Médicale - Institut de Cancérologie de Lorraine
City
Vandoeuvre lès Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Service de Médecine Oncologique - Institut de Cancérologie Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Centro di Riferimento Oncologico - CRO,IRCCS
City
Aviano
Country
Italy
Facility Name
Azienda Ulss 21 Legnago
City
Legnago
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale Tumori
City
Milano
Country
Italy
Facility Name
Ulls13 - Mirano
City
Mirano
Country
Italy
Facility Name
Ospedale Nuovo di Sassuolo
City
Sassuolo
Country
Italy
Facility Name
Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo
City
Torino
Country
Italy
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
33885718
Citation
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. Erratum In: JAMA Oncol. 2021 Jun 1;7(6):945.
Results Reference
derived
Links:
URL
http://www.arcagy.org
Description
Related Info
URL
http://www.esgo.org/engot/Pages/AboutENGOT.aspx
Description
Related Info

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

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