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

Study Overview
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Brief Summary
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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
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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)®.

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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Yondelis®-Caelyx®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Yondelis®-Caelyx®-relapse ovarian cancer<br>Yondelis®-Caelyx®-relapse ovarian cancer | Drug: Yondelis®-Caelyx®<br>* Observation of Yondelis®-Caelyx® administration<br>* Other names: Observation of Yondelis®-Caelyx® administration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Characteristics of the population registered | Describe the population that will be registered | 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) | 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. | 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 | 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. | during treatment and follow up period (maximum of 12 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian cancer, fallopian tube or primary peritoneal, relapse, platinum-sensitive, Yondelis®-Caelyx®