Ovarian Cancer
Conditions
Keywords
ovarian cancer, fallopian tube or primary peritoneal, relapse, platinum-sensitive, Yondelis®-Caelyx®
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)®.
Interventions
DRUGYondelis®-Caelyx®
Observation of Yondelis®-Caelyx® administration
Sponsors
PharmaMar
ARCAGY/ GINECO GROUP
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Characteristics of the population registered | at baseline | Describe the population that will be registered |
| 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) |
| 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 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 |
| 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. |
| 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. |
Countries
France
Outcome results
None listed