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
1 other identifier
observational
101
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2014
Longer than P75 for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2014
CompletedFirst Posted
Study publicly available on registry
June 16, 2014
CompletedStudy Start
First participant enrolled
July 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2018
CompletedSeptember 30, 2020
September 1, 2020
2.6 years
May 28, 2014
September 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the proportion of patient partially versus fully platinum-sensitive in relapse ovarian cancer
To assess patient safety and the tolerance of Yondelis®-Caelyx® administered regarding the daily practice of the oncologist.
Patient will be followed during 12 months
Secondary Outcomes (6)
Choice of treatment
at baseline
Characteristics of the population registered
at baseline
Evaluation of the modality of use of Yondelis®-Caelyx®
during treatment (expected period = 6 months)-As it is an non interventionnal study, treatment period corresponds to the routine practice of each investigator
Safety according to CTCAE v4.03 criteria
Patient will be followed during 12 months
Evaluation of clinical benefit
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.
- +1 more secondary outcomes
Study Arms (1)
Yondelis®-Caelyx®-relapse ovarian cancer
Yondelis®-Caelyx®-relapse ovarian cancer
Interventions
Observation of Yondelis®-Caelyx® administration
Eligibility Criteria
Patients with epithelial ovarian cancer, fallopian tube or peritoneal with treatment receiving in relapse platinum-sensitive
You may qualify if:
- 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
You may not qualify if:
- Patient participation in a clinical trial
- Patient non-affiliated to a social security scheme.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ARCAGY/ GINECO GROUPlead
- PharmaMarcollaborator
Study Sites (33)
Centre de Radiothérapie et d'Oncologie
Agen, France
Clinique de l'Europe
Amiens, France
ICO Paul Papin
Angers, 49100, France
Hôpital de la Côte Basque
Bayonne, 64100, France
Hôpital jean Minjoz
Besançon, France
Clinique Tivoli
Bordeaux, France
Hôpital Fleyriat
Bourg-en-Bresse, France
Hôpital Morvan - Centre Hospitalier Universitaire
Brest, 29200, France
Cabinet d'Oncologie - Hôpital Privé Sainte Marie
Chalon-sur-Saône, 71100, France
Centre Hospitalier de Cholet
Cholet, France
Hôpital Privé Drôme Ardèche - Clinique Pasteur
Guilherand-Granges, 07500, France
Hôpital Louis Pasteur
Le Coudray, 28630, France
Centre Oscar Lambret
Lille, France
Centre Hospitalier Universitaire Dupuytren
Limoges, 87042, France
CHU Dupuytren
Limoges, France
Centre Léon Bérard
Lyon, 69373, France
institut Paoli Calmette
Marseille, France
Centre Azuréen de Cancérologie
Mougins, France
Centre d'oncologie de Gentilly
Nancy, France
Centre Hospitalier Régional
Orléans, France
Hôpital Tenon
Paris, 75020, France
Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie
Poitiers, 86021, France
Clinique Courlancy
Reims, 51100, France
Institut Jean Godinot
Reims, France
Clinique Armoricaine de Radiologie
Saint-Brieuc, France
Clinique de l'Alliance
Saint-Cyr-sur-Loire, France
ICO Centre René Gauducheau
Saint-Herblain, 44805, France
Clinique de l'Union
Saint-Jean, 31240, France
GHPSO - Site Senlis
Senlis, 60309, France
Centre de Radiothérapie - Clinique Sainte-Anne
Strasbourg, 67000, France
Clinique Saint Jean
Toulon, France
Institut Claudius Regaud
Toulouse, 31059, France
Institut de Cancérologie Gustave Roussy
Villejuif, 94805, France
Related Publications (1)
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.
PMID: 32620635RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric SELLE, MD
Hôpital Tenon
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2014
First Posted
June 16, 2014
Study Start
July 10, 2014
Primary Completion
March 1, 2017
Study Completion
September 18, 2018
Last Updated
September 30, 2020
Record last verified: 2020-09