Ovarian Cancer Treatment Platinum-sensitive Relapse - Cohort Study (PROSPECTYON)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02163720|
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : September 30, 2020
|Condition or disease||Intervention/treatment|
|Ovarian Cancer||Drug: Yondelis®-Caelyx®|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||101 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Non Interventional Study Dealing With the Use of Trabectedin (Yondelis®)-Pegylated Liposomal Doxorubicin (Caelyx®) in Patient With Platinum-sensitive Relapse|
|Actual Study Start Date :||July 10, 2014|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||September 18, 2018|
Yondelis®-Caelyx®-relapse ovarian cancer
Yondelis®-Caelyx®-relapse ovarian cancer
Observation of Yondelis®-Caelyx® administration
Other Name: Observation of Yondelis®-Caelyx® administration
- Evaluate the proportion of patient partially versus fully platinum-sensitive in relapse ovarian cancer [ Time Frame: 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.
- Choice of treatment [ Time Frame: 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)
- Characteristics of the population registered [ Time Frame: at baseline ]Describe the population that will be registered
- Evaluation of the modality of use of Yondelis®-Caelyx® [ 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 ]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)
- Safety according to CTCAE v4.03 criteria [ Time Frame: 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 [ 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. ]
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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163720
|Principal Investigator:||Frédéric SELLE, MD||Hôpital Tenon|