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

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Yondelis®-Caelyx®

• Registration Number: NCT02163720
• Lead Sponsor: ARCAGY/ GINECO GROUP

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)®.

Study Timeline

• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-16
• Study Start: 2014-07-10
• Primary Completion: 2017-03
• Study Completion: 2018-09-18
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Yondelis®-Caelyx®-relapse ovarian cancer	Yondelis®-Caelyx®	Yondelis®-Caelyx®-relapse ovarian cancer

Primary Outcome Measures

Name	Time	Method
Evaluate the proportion of patient partially versus fully platinum-sensitive in relapse ovarian cancer	Patient will be followed during 12 months	To assess patient safety and the tolerance of Yondelis®-Caelyx® administered regarding the daily practice of the oncologist.

Secondary Outcome Measures

Name	Time	Method
Safety according to CTCAE v4.03 criteria	Patient will be followed during 12 months	To assess patient safety and the tolerance of Yondelis®-Caelyx® administered regarding the daily practice of the oncologist.
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.	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
Characteristics of the population registered	at baseline	Describe the population that will be registered
Choice of treatment	at baseline	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)
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	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)
Efficacy of treatments	during treatment and follow up period (maximum of 12 months)	Evaluate the efficacy of Yondelis®-Caelyx® in terms of progression-free survival (PFS), Overall Survival (OS), response to treatment.

Trial Locations

Locations (33)

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

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