Clinical trial NCT02163720: Ovarian Cancer Treatment Platinum-sensitive Relapse - Cohort Study (PROSPECTYON)
Official title: Non Interventional Study Dealing With the Use of Trabectedin (Yondelis®)-Pegylated Liposomal Doxorubicin (Caelyx®) in Patient With Platinum-sensitive Relapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: ovarian cancer
fallopian tube or primary peritoneal
relapse
platinum-sensitive
Yondelis®-Caelyx®
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
Collaborators: name: PharmaMar
First posted: 2014-06-16
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with epithelial ovarian cancer, fallopian tube or peritoneal with treatment receiving in relapse platinum-sensitive

Brief summary: 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: 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)®.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the proportion of patient partially versus fully platinum-sensitive in relapse ovarian cancer
timeFrame: Patient will be followed during 12 months
Secondary outcomes:
measure: Choice of treatment
timeFrame: at baseline
measure: Characteristics of the population registered
timeFrame: at baseline
measure: Evaluation of the modality of use of Yondelis®-Caelyx®
timeFrame: during treatment (expected period = 6 months)-As it is an non interventionnal study, treatment period corresponds to the routine practice of each investigator
measure: Safety according to CTCAE v4.03 criteria
timeFrame: Patient will be followed during 12 months
measure: Evaluation of clinical benefit
timeFrame: 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.
measure: Efficacy of treatments
timeFrame: during treatment and follow up period (maximum of 12 months)
Other outcomes:
Locations:
city: Agen
country: France
facility: Centre de Radiothérapie et d'Oncologie
city: Amiens
country: France
facility: Clinique de l'Europe
city: Angers
country: France
facility: ICO Paul Papin
city: Bayonne
country: France
facility: Hôpital de la Côte Basque
city: Besancon
country: France
facility: Hôpital jean Minjoz
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Bourg-En-Bresse
country: France
facility: Hôpital Fleyriat
city: Brest
country: France
facility: Hôpital Morvan - Centre Hospitalier Universitaire
city: Chalon Sur Saone
country: France
facility: Cabinet d'Oncologie - Hôpital Privé Sainte Marie
city: Cholet
country: France
facility: Centre Hospitalier de Cholet
city: Guilherand-granges
country: France
facility: Hôpital Privé Drôme Ardèche - Clinique Pasteur
city: Le Coudray
country: France
facility: Hôpital Louis Pasteur
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: Centre Hospitalier Universitaire Dupuytren
city: Limoges
country: France
facility: CHU Dupuytren
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: institut Paoli Calmette
city: Mougins
country: France
facility: Centre Azuréen de Cancérologie
city: Nancy
country: France
facility: Centre d'oncologie de Gentilly
city: Orléans
country: France
facility: Centre Hospitalier Régional
city: Paris
country: France
facility: Hôpital Tenon
city: Poitiers
country: France
facility: Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie
city: Reims
country: France
facility: Clinique Courlancy
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint Brieuc
country: France
facility: Clinique Armoricaine de Radiologie
city: Saint Herblain
country: France
facility: ICO Centre René Gauducheau
city: Saint Jean
country: France
facility: Clinique de l'Union
city: Saint-cyr-sur-loire
country: France
facility: Clinique de l'Alliance
city: Senlis
country: France
facility: GHPSO - Site Senlis
city: Strasbourg
country: France
facility: Centre de Radiothérapie - Clinique Sainte-Anne
city: Toulon
country: France
facility: Clinique Saint Jean
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Villejuif
country: France
facility: Institut de Cancérologie Gustave Roussy
Study officials:
affiliation: Hôpital Tenon
name: Frédéric SELLE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.