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INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer (INOVATYON)

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Carboplatin
Pegylated Lipoxomal Doxorubicin (PLD)
Trabectedin
Sponsored by
Mario Negri Institute for Pharmacological Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. Female, aged ≥ 18 years
  2. Histologically and/or cytologically proven epithelial ovarian, epithelial fallopian tube cancer or primary peritoneal cancer
  3. Progression free interval between six and twelve (6-12) months (calculated from the first day of the last cycle of the last platinum-based chemotherapy until the date of progression confirmation through radiologic imagery). Patients may have received up to two platinum-based chemotherapy lines, of which at least one must have contained a taxane
  4. Measurable or evaluable disease confirmed by radiological imaging, such as magnetic resonance imaging (MRI), computed tomography (CT) scan, or PET/CT scan at study entry (CA-125 rise not supported by radiological evidence of disease is not accepted as criteria for defining progression) or histological proven recurrent ovarian cancer even in the absence of postoperatively measurable or evaluable lesions.
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
  6. Estimated life expectancy ≥ 12 weeks
  7. Patients must be accessible for treatment and follow-up
  8. Adequate organ function within 14 days prior to first cycle as evidenced
  9. Patients must be able to receive dexamethasone or its equivalent, which is required if randomly assigned to treatment with trabectedin plus PLD
  10. Informed consent of the patient

Exclusion Criteria:

  1. Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors)
  2. Patients who did not respond to last platinum-based therapy or in whom last relapse occurred < 6 months or > 12 months from the last dose of platinum
  3. Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases
  4. Pre-existing grade > 1 motor or sensory neuropathy according to the National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.0
  5. Myocardial infarct within six months before enrolment, New York Association (NYHA) Class II or worse heart failure (Appendix 1. The New York Heart Association), uncontrolled angina, severe uncontrolled ventricular arrythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
  6. History of liver disease
  7. Concurrent severe medical problems or any unstable medical condition unrelated to malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
  8. Breastfeeding women and women of child bearing potential must use effective contraception during treatment and 3 months thereafter, which may include prescription contraceptives (oral, injection, or patch), intrauterine device, double-barrier method or male partner sterilization (not applicable to patients that are surgically sterile)
  9. Prior exposure to trabectedin
  10. Prior resistance to anthracyclines or PLD defined as a progression during anthracycline-based chemotherapy or a recurrence within 6 months from its ending
  11. Prior severe PLD related toxicity
  12. Prior exposure to cumulative doses of doxorubicin >400mg/m2 or epirubicin >720mg/m2
  13. Treatment with any investigational product within 30 days prior to inclusion in the study

Sites / Locations

  • Krankenhaus Der Barmherzigen Brueder
  • Univ. Clinic for Gynaecology and Obstetrics - Medical University of Innsbruck
  • Medizinische Universitat Graz
  • Univ. Klinik Frauenheilkunde AKH
  • Imeldaziekenhuis
  • AZ Klina
  • Antwerp University Hospital
  • UZ Leuven
  • CMSE Clinique et Maternité Sainte-Elisabeth
  • Az Damiaan
  • Centrum Voor Oncologie
  • Centre Hospitalier Peltzer La Tourelle (CHPLT)
  • CHU Dinant Godinne / UCL Namur
  • AZ Maria Middelares
  • UZ Gent
  • Odense University Hospital
  • Tampere University Hospital
  • Kuopio University Hospital - Kuopio
  • Oulu University Hospital
  • Charite Universitaetsmedizin
  • Ev. Waldkrankenhaus Spandau
  • Praxis Dr. med. Jörg Schilling
  • Praxisklinik Krebsheilkunde für Frauen
  • Vivantes Netzwerk für Gesundheit GmbH
  • University Hospital Dresden
  • Dr. med. Georg Heinrich Schwerpunktpraxis für Gynäkologische Onkologie
  • Kath. Marienkrankenhaus
  • Universitäts - Frauenklinik -Tübingen
  • Helios Klinikum Krefeld
  • "Universitätsklinikum Schleswig-Holstein
  • Staedtisches Klinikum Brandenburg
  • Universitatsfrauenklinik Dusseldorf
  • Kliniken Essen Mitte Evang. Huyssens Stiftung
  • University Medical Center Hamburg
  • Universitaetsklinikum Jena
  • Klinikum Leverkusen gGmbH
  • Studienzentrum Onkologie
  • UFK am Klinikum Suedstadt Rostock
  • Onkologische Schwerpunktpraxis
  • Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
  • Ospedale Regionale Umberto Parini
  • "Ospedale Degli Infermi - Biella"
  • Policlinico S.Orsola Malpighi
  • P.O. "A.Perrino" ASL Brindisi
  • A.O. Spedali Civili di Brescia
  • Fondazione Poliambulanza
  • Azienda Ospedaliera S. Croce e Carle
  • Ospedale Valduce
  • Azienda Ospedaliero Universitaria "Policlinico- Vittorio Emanuele" P.O. Gaspare Rodolico
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) - IRCCS, Meldola e Cesena
  • Ospedale San Giuseppe - Azienda USL11
  • Ospedale SS Trinità - Sora
  • Ente Ospedaliero Ospedali Galliera
  • IRCCS San Martino IST - Genova
  • AO della Provincia di Lecco - Ospedale Alessandro Manzoni
  • Ospedale Vito Fazzi
  • European Institute of Oncology, Department of Surgery Science
  • Azienda Ospedaliero Universitaria Policlinico di Modena
  • AO Ospedali Riuniti Villa Sofia Cervello
  • Ospedale Guglielmo da Saliceto - Piacenza
  • Istituto Oncologico Veneto
  • Ospedale Santa Chiara
  • Nuovo Ospedale di Prato S. Stefano
  • Istituto di Ricovero e Cura a Carattere Scientifico - Centro Regionale Oncologico Basilicata
  • Ospedale di Faenza
  • Ospedale Umberto I
  • Azienda Ospedaliera "Bianchi - Melacrino - Morelli"
  • IRCCS - Arcispedale S. Maria Nuova
  • Policlinico Umberto I, Universitàdi Roma "La Sapienza"
  • Ospedale Infermi
  • Ospedale Civile di Sondrio
  • Ospedale di Santa Chiara
  • Fondazione Piemontese Per L'Oncologia - IRCCS, Candiolo
  • AOU Città della salute e della scienza - OIRM S. Anna
  • Ospedale Mauriziano
  • Azienda Ospedaliero Universitaria Città Della Salute e Della Scienza di Torino - P.O. S. Anna
  • Ospedale Del Ponte - Varese
  • U.L.S.S. 13 Mirano - Dolo - Noale
  • Sacro Cuore Don Calabria
  • AOU Materdomini
  • Università degli Studi di Napoli Federico II
  • AOU Maggiore della Carità
  • Presidio Ospedaliero A Tortora
  • ARNAS Civico
  • Casa di Cura La Maddalena
  • Ospedale S. Vincenzo
  • ASL VC Ospedale S. Andrea - Vercelli
  • Radboud University Medical Centre
  • Radium Hospitalet Oslo University Hospital
  • Stavanger University Hospital
  • University Hospital of North Norway
  • Hospital General Universitario de Elche
  • Hospital Germans Trias I Pujol
  • Institut Català d´Oncologia, Hospitalet - Hospitalet de Llobregat
  • Consorcio Hospitalario Provincial de Castellon
  • Institut Català d'Oncologia de Girona
  • H. U. Arnau de Vilanova
  • MD Anderson Cancer Center
  • Althaia
  • Hospital Universitario J.M. Morales Meseguer
  • Hospital Son Espases
  • Hospital Son Llatzer
  • Complejo Hospitalario de Navarra
  • Corporacion Sanitaria y Universitaria Parc Tauli
  • Hospital Universitario Donostia - San Sebastian
  • Hospital General Universitario de Valencia
  • Hospital La Fe
  • IVO Instituto Valenciano de Oncologia
  • Hospital Reina Sofia
  • Hospital Clinico Universitario Virgen De La Arrixaca
  • Hospital Universitario 12 de Octubre
  • Consorci Sanitari De Terrassa
  • Hospital Lluis Alcanyis Xativa
  • Hospital Universitario Dr Peset
  • Kantonsspital Aarau
  • Frauenklinik -Universitätsspital Basel
  • Klinik Engeried
  • Universitätsklinik für Frauenheilkunde, Universitätsklinik für Onkologische Medizin - Inselspital
  • Kantonsspital Graubünden
  • Kantonsspital Frauenfeld
  • Luzerner Kantonsspital
  • Kantonsspital Münsterlingen
  • Kantonsspital Olten
  • Kantonsspital St. Gallen
  • Kantonsspital
  • Frauenklinik - Stadtspital Triemli
  • Ospedale Regionale Bellinzona e Valli - Istituto Oncologico Della Svizzera Italiana (IOSI)
  • Royal Sussex County Hospital
  • Velindre Cancer Center
  • Beatson West of Scotland Cancer Centre
  • The Churchill Hospital
  • Worthingh Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Carboplatin plus PLD

Trabectedin plus PLD

Arm Description

Pegylated Lipoxomal Doxorubicin (PLD) 30 mg/ m2 followed by carboplatin AUC 5.

Pegylated Lipoxomal Doxorubicin (PLD) 30 mg/m2 infusion followed by trabectedin 1.1 mg/m2 infusion.

Outcomes

Primary Outcome Measures

Overall survival (OS)
This is an event driven study. The study will continue until 442 events have occurred.

Secondary Outcome Measures

Progression Free Survival (PFS)
PFS will be measured from the date of randomization to the date of documented PD or death (regardless of cause of death).
Objective RR
Objective RR will be the best response obtained in any evaluation according to RECIST 1.1
CA-125 serological response
CA-125 serological response will be the best response obtained in each arm
Duration of Response
Duration of response: will be calculated from the date of first documentation of response (CR or partial response [PR], whichever occurs first) to the date of documented PD or death.
Time to subsequent chemotherapy administration
The time from randomization to subsequent chemotherapy counted from the administration of subsequent chemotherapy will be evaluated as an exploratory analysis.
OS for Subsequent chemotherapies
the overall survival counted from the administration of subsequent chemotherapy until death
PFS for the Subsequent Chemotherapies
the progression free survival counted from the administration of subsequent chemotherapy untill disease progression or death whichever occurs first
Frequency of serious adverse events (SAEs)
Number of SAEs for each randomization arm
QoL according to the EORTC QLQ-C30 and QLQ-OV28
Two PRO instruments will be administered in this study: the EORTC QLQ-C30 and QLQ-OV28.PRO instruments will be completed by the patient at screening (before randomization) and within four weeks after the 6th cycle or at the time of progression, whichever occurs first.
Best response to each Subsequent chemotherapy line
The best response obtained to each Subsequent chemotherapy line calculated as frequency of patients with CR, PR, SD or PD.
Frequency of toxicities, graded according to the NCI-CTAE version 4.0
Clinical and laboratory toxicities
Frequency of toxicities leading to dose delays
Clinical and laboratory toxicities
Frequency of toxicities leading to dose modifications
Clinical and laboratory toxicities
Frequency of toxicities leading to treatment discontinuation
Clinical and laboratory toxicities

Full Information

First Posted
June 1, 2011
Last Updated
February 8, 2022
Sponsor
Mario Negri Institute for Pharmacological Research
Collaborators
PharmaMar, Averion International Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01379989
Brief Title
INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer
Acronym
INOVATYON
Official Title
Phase III International, Randomized Study of Trabectedin Plus Pegylated Liposomal Doxorubicin (PLD) Versus Carboplatin Plus PLD in Patients With Ovarian Cancer Progressing Within 6-12 Months of Last Platinum
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 17, 2020 (Actual)
Study Completion Date
December 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mario Negri Institute for Pharmacological Research
Collaborators
PharmaMar, Averion International Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this multicentric, randomised, Phase III study is to demonstrate superiority, in terms of survival, of trabectedin and Pegylated Liposomal Doxorubicin (PLD) versus carboplatin and PLD in partially-platinum sensitive ovarian cancer patients.
Detailed Description
Patients will be randomised to: Arm A: PLD 30 mg/m2 and carboplatin AUC 5; Arm B: PLD 30 mg/m2 and trabectedin 1.1 mg/m2. Patients' characteristics: patients over 18 years of age with advanced, progressive ovarian cancer 6-12 months after completion of first line or second line treatment with platinum-based chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
617 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carboplatin plus PLD
Arm Type
Active Comparator
Arm Description
Pegylated Lipoxomal Doxorubicin (PLD) 30 mg/ m2 followed by carboplatin AUC 5.
Arm Title
Trabectedin plus PLD
Arm Type
Experimental
Arm Description
Pegylated Lipoxomal Doxorubicin (PLD) 30 mg/m2 infusion followed by trabectedin 1.1 mg/m2 infusion.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Carboplatin generic
Intervention Description
Carboplatin AUC 5
Intervention Type
Drug
Intervention Name(s)
Pegylated Lipoxomal Doxorubicin (PLD)
Other Intervention Name(s)
Caelyx
Intervention Description
PLD 30 mg/m² i.v.
Intervention Type
Drug
Intervention Name(s)
Trabectedin
Other Intervention Name(s)
Yondelis
Intervention Description
trabectedin 1.1 mg/m2 3-hour i.v. infusion on Day 1 every 3 weeks. The use of central venous access is strongly recommended.
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
This is an event driven study. The study will continue until 442 events have occurred.
Time Frame
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS will be measured from the date of randomization to the date of documented PD or death (regardless of cause of death).
Time Frame
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Title
Objective RR
Description
Objective RR will be the best response obtained in any evaluation according to RECIST 1.1
Time Frame
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Title
CA-125 serological response
Description
CA-125 serological response will be the best response obtained in each arm
Time Frame
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Title
Duration of Response
Description
Duration of response: will be calculated from the date of first documentation of response (CR or partial response [PR], whichever occurs first) to the date of documented PD or death.
Time Frame
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Title
Time to subsequent chemotherapy administration
Description
The time from randomization to subsequent chemotherapy counted from the administration of subsequent chemotherapy will be evaluated as an exploratory analysis.
Time Frame
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Title
OS for Subsequent chemotherapies
Description
the overall survival counted from the administration of subsequent chemotherapy until death
Time Frame
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Title
PFS for the Subsequent Chemotherapies
Description
the progression free survival counted from the administration of subsequent chemotherapy untill disease progression or death whichever occurs first
Time Frame
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Title
Frequency of serious adverse events (SAEs)
Description
Number of SAEs for each randomization arm
Time Frame
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Title
QoL according to the EORTC QLQ-C30 and QLQ-OV28
Description
Two PRO instruments will be administered in this study: the EORTC QLQ-C30 and QLQ-OV28.PRO instruments will be completed by the patient at screening (before randomization) and within four weeks after the 6th cycle or at the time of progression, whichever occurs first.
Time Frame
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Title
Best response to each Subsequent chemotherapy line
Description
The best response obtained to each Subsequent chemotherapy line calculated as frequency of patients with CR, PR, SD or PD.
Time Frame
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Title
Frequency of toxicities, graded according to the NCI-CTAE version 4.0
Description
Clinical and laboratory toxicities
Time Frame
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Title
Frequency of toxicities leading to dose delays
Description
Clinical and laboratory toxicities
Time Frame
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Title
Frequency of toxicities leading to dose modifications
Description
Clinical and laboratory toxicities
Time Frame
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint
Title
Frequency of toxicities leading to treatment discontinuation
Description
Clinical and laboratory toxicities
Time Frame
This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female, aged ≥ 18 years Histologically and/or cytologically proven epithelial ovarian, epithelial fallopian tube cancer or primary peritoneal cancer Progression free interval between six and twelve (6-12) months (calculated from the first day of the last cycle of the last platinum-based chemotherapy until the date of progression confirmation through radiologic imagery). Patients may have received up to two platinum-based chemotherapy lines, of which at least one must have contained a taxane Measurable or evaluable disease confirmed by radiological imaging, such as magnetic resonance imaging (MRI), computed tomography (CT) scan, or PET/CT scan at study entry (CA-125 rise not supported by radiological evidence of disease is not accepted as criteria for defining progression) or histological proven recurrent ovarian cancer even in the absence of postoperatively measurable or evaluable lesions. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 Estimated life expectancy ≥ 12 weeks Patients must be accessible for treatment and follow-up Adequate organ function within 14 days prior to first cycle as evidenced Patients must be able to receive dexamethasone or its equivalent, which is required if randomly assigned to treatment with trabectedin plus PLD Informed consent of the patient Exclusion Criteria: Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors) Patients who did not respond to last platinum-based therapy or in whom last relapse occurred < 6 months or > 12 months from the last dose of platinum Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases Pre-existing grade > 1 motor or sensory neuropathy according to the National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.0 Myocardial infarct within six months before enrolment, New York Association (NYHA) Class II or worse heart failure (Appendix 1. The New York Heart Association), uncontrolled angina, severe uncontrolled ventricular arrythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities History of liver disease Concurrent severe medical problems or any unstable medical condition unrelated to malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy Breastfeeding women and women of child bearing potential must use effective contraception during treatment and 3 months thereafter, which may include prescription contraceptives (oral, injection, or patch), intrauterine device, double-barrier method or male partner sterilization (not applicable to patients that are surgically sterile) Prior exposure to trabectedin Prior resistance to anthracyclines or PLD defined as a progression during anthracycline-based chemotherapy or a recurrence within 6 months from its ending Prior severe PLD related toxicity Prior exposure to cumulative doses of doxorubicin >400mg/m2 or epirubicin >720mg/m2 Treatment with any investigational product within 30 days prior to inclusion in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicoletta Colombo, MD
Organizational Affiliation
European Institute of Oncology (I.E.O), Milan, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krankenhaus Der Barmherzigen Brueder
City
Graz
State/Province
AT
ZIP/Postal Code
8020
Country
Austria
Facility Name
Univ. Clinic for Gynaecology and Obstetrics - Medical University of Innsbruck
City
Innsbruck
State/Province
AT
Country
Austria
Facility Name
Medizinische Universitat Graz
City
Graz
Country
Austria
Facility Name
Univ. Klinik Frauenheilkunde AKH
City
Wien
Country
Austria
Facility Name
Imeldaziekenhuis
City
Bonheiden
State/Province
BE
Country
Belgium
Facility Name
AZ Klina
City
Brasschaat
State/Province
BE
Country
Belgium
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
BE
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
State/Province
BE
Country
Belgium
Facility Name
CMSE Clinique et Maternité Sainte-Elisabeth
City
Namur
State/Province
BE
Country
Belgium
Facility Name
Az Damiaan
City
Oostende
State/Province
BE
Country
Belgium
Facility Name
Centrum Voor Oncologie
City
Turnhout
State/Province
BE
Country
Belgium
Facility Name
Centre Hospitalier Peltzer La Tourelle (CHPLT)
City
Verviers
State/Province
BE
Country
Belgium
Facility Name
CHU Dinant Godinne / UCL Namur
City
Yvoir
State/Province
BE
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
Odense University Hospital
City
Odense
State/Province
DK
Country
Denmark
Facility Name
Tampere University Hospital
City
Tampere
State/Province
FI
ZIP/Postal Code
33521
Country
Finland
Facility Name
Kuopio University Hospital - Kuopio
City
Kuopio
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Charite Universitaetsmedizin
City
Berlin
State/Province
DE
ZIP/Postal Code
10117
Country
Germany
Facility Name
Ev. Waldkrankenhaus Spandau
City
Berlin
State/Province
DE
Country
Germany
Facility Name
Praxis Dr. med. Jörg Schilling
City
Berlin
State/Province
DE
Country
Germany
Facility Name
Praxisklinik Krebsheilkunde für Frauen
City
Berlin
State/Province
DE
Country
Germany
Facility Name
Vivantes Netzwerk für Gesundheit GmbH
City
Berlin
State/Province
DE
Country
Germany
Facility Name
University Hospital Dresden
City
Dresden
State/Province
DE
Country
Germany
Facility Name
Dr. med. Georg Heinrich Schwerpunktpraxis für Gynäkologische Onkologie
City
Fürstenwalde
State/Province
DE
Country
Germany
Facility Name
Kath. Marienkrankenhaus
City
Hamburg
State/Province
DE
Country
Germany
Facility Name
Universitäts - Frauenklinik -Tübingen
City
Heidelberg
State/Province
DE
Country
Germany
Facility Name
Helios Klinikum Krefeld
City
Krefeld
State/Province
DE
Country
Germany
Facility Name
"Universitätsklinikum Schleswig-Holstein
City
Lübeck
State/Province
DE
Country
Germany
Facility Name
Staedtisches Klinikum Brandenburg
City
Brandenburg an der Havel
Country
Germany
Facility Name
Universitatsfrauenklinik Dusseldorf
City
Dusseldorf
Country
Germany
Facility Name
Kliniken Essen Mitte Evang. Huyssens Stiftung
City
Essen
Country
Germany
Facility Name
University Medical Center Hamburg
City
Hamburg
Country
Germany
Facility Name
Universitaetsklinikum Jena
City
Jena
Country
Germany
Facility Name
Klinikum Leverkusen gGmbH
City
Leverkusen
Country
Germany
Facility Name
Studienzentrum Onkologie
City
Ravensburg
Country
Germany
Facility Name
UFK am Klinikum Suedstadt Rostock
City
Rostock
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Speyer
Country
Germany
Facility Name
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
City
Alessandria
State/Province
AL
Country
Italy
Facility Name
Ospedale Regionale Umberto Parini
City
Aosta
State/Province
AO
Country
Italy
Facility Name
"Ospedale Degli Infermi - Biella"
City
Biella
State/Province
BI
Country
Italy
Facility Name
Policlinico S.Orsola Malpighi
City
Bologna
State/Province
BO
Country
Italy
Facility Name
P.O. "A.Perrino" ASL Brindisi
City
Brindisi
State/Province
BR
Country
Italy
Facility Name
A.O. Spedali Civili di Brescia
City
Brescia
State/Province
BS
Country
Italy
Facility Name
Fondazione Poliambulanza
City
Brescia
State/Province
BS
Country
Italy
Facility Name
Azienda Ospedaliera S. Croce e Carle
City
Cuneo
State/Province
CN
Country
Italy
Facility Name
Ospedale Valduce
City
Como
State/Province
CO
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria "Policlinico- Vittorio Emanuele" P.O. Gaspare Rodolico
City
Catania
State/Province
CT
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) - IRCCS, Meldola e Cesena
City
Meldola
State/Province
FC
Country
Italy
Facility Name
Ospedale San Giuseppe - Azienda USL11
City
Empoli
State/Province
FI
Country
Italy
Facility Name
Ospedale SS Trinità - Sora
City
Sora
State/Province
FR
Country
Italy
Facility Name
Ente Ospedaliero Ospedali Galliera
City
Genova
State/Province
GE
ZIP/Postal Code
16128
Country
Italy
Facility Name
IRCCS San Martino IST - Genova
City
Genova
State/Province
GE
Country
Italy
Facility Name
AO della Provincia di Lecco - Ospedale Alessandro Manzoni
City
Lecco
State/Province
LC
Country
Italy
Facility Name
Ospedale Vito Fazzi
City
Lecce
State/Province
LE
Country
Italy
Facility Name
European Institute of Oncology, Department of Surgery Science
City
Milan
State/Province
MI
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico di Modena
City
Modena
State/Province
MO
Country
Italy
Facility Name
AO Ospedali Riuniti Villa Sofia Cervello
City
Palermo
State/Province
PA
Country
Italy
Facility Name
Ospedale Guglielmo da Saliceto - Piacenza
City
Piacenza
State/Province
PC
Country
Italy
Facility Name
Istituto Oncologico Veneto
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedale Santa Chiara
City
Pisa
State/Province
PI
ZIP/Postal Code
56126
Country
Italy
Facility Name
Nuovo Ospedale di Prato S. Stefano
City
Prato
State/Province
PO
Country
Italy
Facility Name
Istituto di Ricovero e Cura a Carattere Scientifico - Centro Regionale Oncologico Basilicata
City
Rionero in Vulture
State/Province
PZ
Country
Italy
Facility Name
Ospedale di Faenza
City
Faenza
State/Province
RA
Country
Italy
Facility Name
Ospedale Umberto I
City
Lugo
State/Province
RA
Country
Italy
Facility Name
Azienda Ospedaliera "Bianchi - Melacrino - Morelli"
City
Reggio Calabria
State/Province
RC
Country
Italy
Facility Name
IRCCS - Arcispedale S. Maria Nuova
City
Reggio Emilia
State/Province
RE
Country
Italy
Facility Name
Policlinico Umberto I, Universitàdi Roma "La Sapienza"
City
Roma
State/Province
RM
Country
Italy
Facility Name
Ospedale Infermi
City
Rimini
State/Province
RN
Country
Italy
Facility Name
Ospedale Civile di Sondrio
City
Sondrio
State/Province
SO
Country
Italy
Facility Name
Ospedale di Santa Chiara
City
Trento
State/Province
TN
Country
Italy
Facility Name
Fondazione Piemontese Per L'Oncologia - IRCCS, Candiolo
City
Candiolo
State/Province
TO
Country
Italy
Facility Name
AOU Città della salute e della scienza - OIRM S. Anna
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale Mauriziano
City
Torino
State/Province
TO
ZIP/Postal Code
10128
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Città Della Salute e Della Scienza di Torino - P.O. S. Anna
City
Torino
State/Province
TO
Country
Italy
Facility Name
Ospedale Del Ponte - Varese
City
Varese
State/Province
VA
Country
Italy
Facility Name
U.L.S.S. 13 Mirano - Dolo - Noale
City
Mirano
State/Province
VE
Country
Italy
Facility Name
Sacro Cuore Don Calabria
City
Negrar
State/Province
VR
Country
Italy
Facility Name
AOU Materdomini
City
Catanzaro
Country
Italy
Facility Name
Università degli Studi di Napoli Federico II
City
Napoli
Country
Italy
Facility Name
AOU Maggiore della Carità
City
Novara
Country
Italy
Facility Name
Presidio Ospedaliero A Tortora
City
Pagani
Country
Italy
Facility Name
ARNAS Civico
City
Palermo
Country
Italy
Facility Name
Casa di Cura La Maddalena
City
Palermo
Country
Italy
Facility Name
Ospedale S. Vincenzo
City
Taormina
Country
Italy
Facility Name
ASL VC Ospedale S. Andrea - Vercelli
City
Vercelli
Country
Italy
Facility Name
Radboud University Medical Centre
City
Nijmegen
State/Province
NL
ZIP/Postal Code
6525
Country
Netherlands
Facility Name
Radium Hospitalet Oslo University Hospital
City
Oslo
Country
Norway
Facility Name
Stavanger University Hospital
City
Stavanger
Country
Norway
Facility Name
University Hospital of North Norway
City
Tromsø
Country
Norway
Facility Name
Hospital General Universitario de Elche
City
Alicante
State/Province
ES
Country
Spain
Facility Name
Hospital Germans Trias I Pujol
City
Badalona
State/Province
ES
ZIP/Postal Code
08916
Country
Spain
Facility Name
Institut Català d´Oncologia, Hospitalet - Hospitalet de Llobregat
City
Barcellona
State/Province
ES
Country
Spain
Facility Name
Consorcio Hospitalario Provincial de Castellon
City
Castèllo
State/Province
ES
Country
Spain
Facility Name
Institut Català d'Oncologia de Girona
City
Girona
State/Province
ES
Country
Spain
Facility Name
H. U. Arnau de Vilanova
City
Lleida
State/Province
ES
ZIP/Postal Code
25598
Country
Spain
Facility Name
MD Anderson Cancer Center
City
Madrid
State/Province
ES
Country
Spain
Facility Name
Althaia
City
Manresa
State/Province
ES
Country
Spain
Facility Name
Hospital Universitario J.M. Morales Meseguer
City
Murcia
State/Province
ES
Country
Spain
Facility Name
Hospital Son Espases
City
Palma de Mallorca
State/Province
ES
Country
Spain
Facility Name
Hospital Son Llatzer
City
Palma de Mallorca
State/Province
ES
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
State/Province
ES
Country
Spain
Facility Name
Corporacion Sanitaria y Universitaria Parc Tauli
City
Sabadell
State/Province
ES
Country
Spain
Facility Name
Hospital Universitario Donostia - San Sebastian
City
San Sebastian
State/Province
ES
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
State/Province
ES
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
State/Province
ES
Country
Spain
Facility Name
IVO Instituto Valenciano de Oncologia
City
Valencia
State/Province
ES
Country
Spain
Facility Name
Hospital Reina Sofia
City
Cordoba
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen De La Arrixaca
City
El Palmar
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Consorci Sanitari De Terrassa
City
Terrassa
Country
Spain
Facility Name
Hospital Lluis Alcanyis Xativa
City
Valencia
Country
Spain
Facility Name
Hospital Universitario Dr Peset
City
Valencia
Country
Spain
Facility Name
Kantonsspital Aarau
City
Aarau
State/Province
CH
Country
Switzerland
Facility Name
Frauenklinik -Universitätsspital Basel
City
Basel
State/Province
CH
Country
Switzerland
Facility Name
Klinik Engeried
City
Bern
State/Province
CH
Country
Switzerland
Facility Name
Universitätsklinik für Frauenheilkunde, Universitätsklinik für Onkologische Medizin - Inselspital
City
Bern
State/Province
CH
Country
Switzerland
Facility Name
Kantonsspital Graubünden
City
Chur
State/Province
CH
Country
Switzerland
Facility Name
Kantonsspital Frauenfeld
City
Frauenfeld
State/Province
CH
Country
Switzerland
Facility Name
Luzerner Kantonsspital
City
Luzern
State/Province
CH
Country
Switzerland
Facility Name
Kantonsspital Münsterlingen
City
Münsterlingen
State/Province
CH
Country
Switzerland
Facility Name
Kantonsspital Olten
City
Olten
State/Province
CH
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
State/Province
CH
Country
Switzerland
Facility Name
Kantonsspital
City
Winterthur
State/Province
CH
Country
Switzerland
Facility Name
Frauenklinik - Stadtspital Triemli
City
Zürich
State/Province
CH
Country
Switzerland
Facility Name
Ospedale Regionale Bellinzona e Valli - Istituto Oncologico Della Svizzera Italiana (IOSI)
City
Bellinzona
State/Province
TI
Country
Switzerland
Facility Name
Royal Sussex County Hospital
City
Brighton
Country
United Kingdom
Facility Name
Velindre Cancer Center
City
Cardiff
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
Country
United Kingdom
Facility Name
The Churchill Hospital
City
Oxford
Country
United Kingdom
Facility Name
Worthingh Hospital
City
Worthing
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer

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