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.
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 Type
OBSERVATIONAL
Enrollment
101
Observation of Yondelis®-Caelyx® administration
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.
Time frame: Patient will be followed during 12 months
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)
Time frame: at baseline
Characteristics of the population registered
Describe the population that will be registered
Time frame: at baseline
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)
Time frame: 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
To assess patient safety and the tolerance of Yondelis®-Caelyx® administered regarding the daily practice of the oncologist.
Time frame: Patient will be followed during 12 months
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
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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
Besançon, 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-Saône, France
Centre Hospitalier de Cholet
Cholet, France
...and 23 more locations
Time frame: 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.
Efficacy of treatments
Evaluate the efficacy of Yondelis®-Caelyx® in terms of progression-free survival (PFS), Overall Survival (OS), response to treatment.
Time frame: during treatment and follow up period (maximum of 12 months)