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

Ovarian Cancer Clinical Trial

Official title:

Non Interventional Study Dealing With the Use of Trabectedin (Yondelis®)-Pegylated Liposomal Doxorubicin (Caelyx®) in Patient With Platinum-sensitive Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163720
• Other study ID #: PROSPECTYON (GINECO-OV229)
• Status: Completed
• Start date: July 10, 2014
• Est. completion date: September 18, 2018

Study information

• Verified date: September 2020
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 18, 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Hypersensitivity
• Ovarian Cancer
• Ovarian Neoplasms
• Recurrence

Intervention

Drug:
• Yondelis®-Caelyx®
Observation of Yondelis®-Caelyx® administration

Locations

Country	Name	City	State
France	Centre de Radiothérapie et d'Oncologie	Agen
France	Clinique de l'Europe	Amiens
France	ICO Paul Papin	Angers
France	Hôpital de la Côte Basque	Bayonne
France	Hôpital jean Minjoz	Besancon
France	Clinique Tivoli	Bordeaux
France	Hôpital Fleyriat	Bourg-En-Bresse
France	Hôpital Morvan - Centre Hospitalier Universitaire	Brest
France	Cabinet d'Oncologie - Hôpital Privé Sainte Marie	Chalon Sur Saone
France	Centre Hospitalier de Cholet	Cholet
France	Hôpital Privé Drôme Ardèche - Clinique Pasteur	Guilherand-granges
France	Hôpital Louis Pasteur	Le Coudray
France	Centre Oscar Lambret	Lille
France	Centre Hospitalier Universitaire Dupuytren	Limoges
France	CHU Dupuytren	Limoges
France	Centre Léon Bérard	Lyon
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
France	Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie	Poitiers
France	Clinique Courlancy	Reims
France	Institut Jean Godinot	Reims
France	Clinique Armoricaine de Radiologie	Saint Brieuc
France	ICO Centre René Gauducheau	Saint Herblain
France	Clinique de l'Union	Saint Jean
France	Clinique de l'Alliance	Saint-cyr-sur-loire
France	GHPSO - Site Senlis	Senlis
France	Centre de Radiothérapie - Clinique Sainte-Anne	Strasbourg
France	Clinique Saint Jean	Toulon
France	Institut Claudius Regaud	Toulouse
France	Institut de Cancérologie Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP	PharmaMar

Country where clinical trial is conducted

France, 

References & 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: Trabect — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Choice of treatment	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)	at baseline
Secondary	Characteristics of the population registered	Describe the population that will be registered	at baseline
Secondary	Evaluation of the modality of use of Yondelis®-Caelyx®	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)	during treatment (expected period = 6 months)-As it is an non interventionnal study, treatment period corresponds to the routine practice of each investigator
Secondary	Safety according to CTCAE v4.03 criteria	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	Evaluation of clinical benefit	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.
Secondary	Efficacy of treatments	Evaluate the efficacy of Yondelis®-Caelyx® in terms of progression-free survival (PFS), Overall Survival (OS), response to treatment.	during treatment and follow up period (maximum of 12 months)