- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02163720
Ovarian Cancer Treatment Platinum-sensitive Relapse - Cohort Study (PROSPECTYON)
Non Interventional Study Dealing With the Use of Trabectedin (Yondelis®)-Pegylated Liposomal Doxorubicin (Caelyx®) in Patient With Platinum-sensitive Relapse
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Agen, France
- Centre de Radiothérapie et d'Oncologie
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Amiens, France
- Clinique de l'Europe
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Angers, France, 49100
- ICO Paul Papin
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Bayonne, France, 64100
- Hopital de la cote Basque
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Besancon, France
- Hôpital Jean Minjoz
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Bordeaux, France
- Clinique Tivoli
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Bourg-En-Bresse, France
- Hôpital Fleyriat
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Brest, France, 29200
- Hôpital Morvan - Centre Hospitalier Universitaire
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Chalon Sur Saone, France, 71100
- Cabinet d'Oncologie - Hôpital Privé Sainte Marie
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Cholet, France
- Centre Hospitalier de Cholet
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Guilherand-granges, France, 07500
- Hôpital privé Drôme Ardèche - Clinique Pasteur
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Le Coudray, France, 28630
- Hôpital Louis Pasteur
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Lille, France
- Centre Oscar Lambret
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Limoges, France
- CHU Dupuytren
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Limoges, France, 87042
- Centre Hospitalier Universitaire Dupuytren
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Lyon, France, 69373
- Centre Léon Bérard
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Marseille, France
- Institut Paoli Calmette
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Mougins, France
- Centre Azuréen de Cancérologie
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Nancy, France
- Centre d'Oncologie de Gentilly
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Orléans, France
- Centre Hospitalier Régional
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Paris, France, 75020
- Hôpital Tenon
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Poitiers, France, 86021
- Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie
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Reims, France
- Institut Jean Godinot
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Reims, France, 51100
- Clinique Courlancy
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Saint Brieuc, France
- Clinique Armoricaine de Radiologie
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Saint Herblain, France, 44805
- ICO Centre René Gauducheau
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Saint Jean, France, 31240
- Clinique de l'Union
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Saint-cyr-sur-loire, France
- Clinique de l'Alliance
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Senlis, France, 60309
- GHPSO - Site Senlis
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Strasbourg, France, 67000
- Centre de Radiothérapie - Clinique Sainte-Anne
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Toulon, France
- Clinique Saint Jean
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Toulouse, France, 31059
- Institut Claudius Regaud
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Villejuif, France, 94805
- Institut de Cancerologie Gustave Roussy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 years and over,
- Patients with an epithelial ovarian cancer, fallopian tube or peritoneal who will receive Yondelis®-Caelyx® in relapse platinum-sensitive
- Patients should be informed of the study orally and should not have any objection their data to be processed
Exclusion Criteria:
- Patient participation in a clinical trial
- Patient non-affiliated to a social security scheme.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Yondelis®-Caelyx®-relapse ovarian cancer
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Observation of Yondelis®-Caelyx® administration
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the proportion of patient partially versus fully platinum-sensitive in relapse ovarian cancer
Time Frame: Patient will be followed during 12 months
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To assess patient safety and the tolerance of Yondelis®-Caelyx® administered regarding the daily practice of the oncologist.
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Patient will be followed during 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Choice of treatment
Time Frame: at baseline
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Describe the reason why treatment by trabectedin and doxorubicine combination was initiated (ex : number of patients with previous intolerance to platinum as allergic reaction, residual peripherical neuropathy, alopecia; availability of the combination yondelis-caelyx in the treating site; number of sites where the yondelis-caelyx combination is the reference treatment)
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at baseline
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Characteristics of the population registered
Time Frame: at baseline
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Describe the population that will be registered
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at baseline
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Evaluation of the modality of use of Yondelis®-Caelyx®
Time Frame: during treatment (expected period = 6 months)-As it is an non interventionnal study, treatment period corresponds to the routine practice of each investigator
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Describe the way how treatment by Yondelis®-Caelyx® is administered in the daily practice for each patient (Initial dosage of caelyx and yondelis, number of cycles administered for each treatment , dose reductions occurence and reasons)
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during treatment (expected period = 6 months)-As it is an non interventionnal study, treatment period corresponds to the routine practice of each investigator
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Safety according to CTCAE v4.03 criteria
Time Frame: Patient will be followed during 12 months
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To assess patient safety and the tolerance of Yondelis®-Caelyx® administered regarding the daily practice of the oncologist.
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Patient will be followed during 12 months
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Evaluation of clinical benefit
Time Frame: baseline and during treatment (expected period of treatment = 6 months). As it is an non interventionnal study, treatment period corresponds to the routine practice of each investigator.
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Evaluation of clinical benefit will be performed during the physical examination at baseline and during the treatment At baseline : describe the number of patients how present the following related symptom disease : weight loss, ascites, abdominal pain, constipation, fatigue, occlusive syndrome Then, describe the number of patients how presented and improvement or a degradation of theses related symptom disease during the treatment Nota Bene : this cohort study is strictly observational and must represent the daily practice. No indications must be given regarding the frequency of the physical examination |
baseline and during treatment (expected period of treatment = 6 months). As it is an non interventionnal study, treatment period corresponds to the routine practice of each investigator.
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Efficacy of treatments
Time Frame: during treatment and follow up period (maximum of 12 months)
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Evaluate the efficacy of Yondelis®-Caelyx® in terms of progression-free survival (PFS), Overall Survival (OS), response to treatment.
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during treatment and follow up period (maximum of 12 months)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Frédéric SELLE, MD, Hôpital Tenon
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Hypersensitivity
- Recurrence
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Doxorubicin
- Liposomal doxorubicin
- Trabectedin
Other Study ID Numbers
- PROSPECTYON (GINECO-OV229)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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