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| Name | Class |
|---|---|
| PharmaMar | INDUSTRY |
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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.
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)®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yondelis®-Caelyx®-relapse ovarian cancer | Yondelis®-Caelyx®-relapse ovarian cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yondelis®-Caelyx® | Drug | Observation of Yondelis®-Caelyx® administration |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with epithelial ovarian cancer, fallopian tube or peritoneal with treatment receiving in relapse platinum-sensitive
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric SELLE, MD | Hôpital Tenon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Radiothérapie et d'Oncologie | Agen | France | ||||
| Clinique de l'Europe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32620635 | Result | 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: Trabectedin Plus Pegylated Liposomal Doxorubicin for Platinum-sensitive Recurrent Ovarian Cancer. Anticancer Res. 2020 Jul;40(7):3939-3945. doi: 10.21873/anticanres.14385. |
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| 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) |
| Amiens |
| France |
| ICO Paul Papin | Angers | 49100 | France |
| Hôpital de la Côte Basque | Bayonne | 64100 | France |
| Hôpital jean Minjoz | Besançon | France |
| Clinique Tivoli | Bordeaux | France |
| Hôpital Fleyriat | Bourg-en-Bresse | France |
| Hôpital Morvan - Centre Hospitalier Universitaire | Brest | 29200 | France |
| Cabinet d'Oncologie - Hôpital Privé Sainte Marie | Chalon-sur-Saône | 71100 | France |
| Centre Hospitalier de Cholet | Cholet | France |
| Hôpital Privé Drôme Ardèche - Clinique Pasteur | Guilherand-Granges | 07500 | France |
| Hôpital Louis Pasteur | Le Coudray | 28630 | France |
| Centre Oscar Lambret | Lille | France |
| Centre Hospitalier Universitaire Dupuytren | Limoges | 87042 | France |
| CHU Dupuytren | Limoges | France |
| Centre Léon Bérard | Lyon | 69373 | 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 | 75020 | France |
| Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie | Poitiers | 86021 | France |
| Clinique Courlancy | Reims | 51100 | France |
| Institut Jean Godinot | Reims | France |
| Clinique Armoricaine de Radiologie | Saint-Brieuc | France |
| Clinique de l'Alliance | Saint-Cyr-sur-Loire | France |
| ICO Centre René Gauducheau | Saint-Herblain | 44805 | France |
| Clinique de l'Union | Saint-Jean | 31240 | France |
| GHPSO - Site Senlis | Senlis | 60309 | France |
| Centre de Radiothérapie - Clinique Sainte-Anne | Strasbourg | 67000 | France |
| Clinique Saint Jean | Toulon | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| Institut de Cancérologie Gustave Roussy | Villejuif | 94805 | France |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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