Ovarian Cancer Treatment Platinum-sensitive Relapse - Cohort Study (PROSPECTYON)

NCT ID: NCT02163720

Last Updated: 2020-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-10

Study Completion Date

2018-09-18

Brief Summary

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The French cooperative group GINECO proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®, in ovarian platinum sensitive cancer relapse.

Detailed Description

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Population : Patients aged 18 years and older with an epithelial ovarian cancer, fallopian tube or primary peritoneal with platinum-sensitive recurrent witch it was decided to initiate a treatment with trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®.

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Yondelis®-Caelyx®-relapse ovarian cancer

Yondelis®-Caelyx®-relapse ovarian cancer

Yondelis®-Caelyx®

Intervention Type DRUG

Observation of Yondelis®-Caelyx® administration

Interventions

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Yondelis®-Caelyx®

Observation of Yondelis®-Caelyx® administration

Intervention Type DRUG

Other Intervention Names

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Observation of Yondelis®-Caelyx® administration

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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PharmaMar

INDUSTRY

Sponsor Role collaborator

ARCAGY/ GINECO GROUP

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric SELLE, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Tenon

Locations

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Centre de Radiothérapie et d'Oncologie

Agen, , France

Site Status

Clinique de l'Europe

Amiens, , France

Site Status

ICO Paul Papin

Angers, , France

Site Status

Hôpital de la Côte Basque

Bayonne, , France

Site Status

Hôpital jean Minjoz

Besançon, , France

Site Status

Clinique Tivoli

Bordeaux, , France

Site Status

Hôpital Fleyriat

Bourg-en-Bresse, , France

Site Status

Hôpital Morvan - Centre Hospitalier Universitaire

Brest, , France

Site Status

Cabinet d'Oncologie - Hôpital Privé Sainte Marie

Chalon-sur-Saône, , France

Site Status

Centre Hospitalier de Cholet

Cholet, , France

Site Status

Hôpital Privé Drôme Ardèche - Clinique Pasteur

Guilherand-Granges, , France

Site Status

Hôpital Louis Pasteur

Le Coudray, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Centre Hospitalier Universitaire Dupuytren

Limoges, , France

Site Status

CHU Dupuytren

Limoges, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

institut Paoli Calmette

Marseille, , France

Site Status

Centre Azuréen de Cancérologie

Mougins, , France

Site Status

Centre d'oncologie de Gentilly

Nancy, , France

Site Status

Centre Hospitalier Régional

Orléans, , France

Site Status

Hôpital Tenon

Paris, , France

Site Status

Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie

Poitiers, , France

Site Status

Clinique Courlancy

Reims, , France

Site Status

Institut Jean Godinot

Reims, , France

Site Status

Clinique Armoricaine de Radiologie

Saint-Brieuc, , France

Site Status

Clinique de l'Alliance

Saint-Cyr-sur-Loire, , France

Site Status

ICO Centre René Gauducheau

Saint-Herblain, , France

Site Status

Clinique de l'Union

Saint-Jean, , France

Site Status

GHPSO - Site Senlis

Senlis, , France

Site Status

Centre de Radiothérapie - Clinique Sainte-Anne

Strasbourg, , France

Site Status

Clinique Saint Jean

Toulon, , France

Site Status

Institut Claudius Regaud

Toulouse, , France

Site Status

Institut de Cancérologie Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

References

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Selle F, Heudel PE, Hardy-Bessard AC, Pozet A, Meunier J, Gladieff L, Lotz JP, Provansal M, Augereau P, Berton D, Bonichon-Lamichhane N, Orfeuvre H, Pautier P, Kalbacher E, Tazi Y, Spaeth D. GINECO Prospective Non-interventional PROSPECTYON Study: Trabectedin Plus Pegylated Liposomal Doxorubicin for Platinum-sensitive Recurrent Ovarian Cancer. Anticancer Res. 2020 Jul;40(7):3939-3945. doi: 10.21873/anticanres.14385.

Reference Type RESULT
PMID: 32620635 (View on PubMed)

Other Identifiers

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PROSPECTYON (GINECO-OV229)

Identifier Type: -

Identifier Source: org_study_id

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