Overview

This trial is active, not recruiting.

Condition ovarian cancer
Treatment yondelis®-caelyx®
Sponsor ARCAGY/ GINECO GROUP
Collaborator PharmaMar
Start date June 2014
End date October 2016
Trial size 101 participants
Trial identifier NCT02163720, PROSPECTYON (GINECO-OV229)

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Yondelis®-Caelyx®-relapse ovarian cancer
yondelis®-caelyx® Observation of Yondelis®-Caelyx® administration
Observation of Yondelis®-Caelyx® administration

Primary Outcomes

Measure
Evaluate the proportion of patient partially versus fully platinum-sensitive in relapse ovarian cancer
time frame: Patient will be followed during 12 months

Secondary Outcomes

Measure
Choice of treatment
time frame: at baseline
Characteristics of the population registered
time frame: at baseline
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
Safety according to CTCAE v4.03 criteria
time frame: Patient will be followed during 12 months
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.
Efficacy of treatments
time frame: during treatment and follow up period (maximum of 12 months)

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Non Interventional Study Dealing With the Use of Trabectedin (Yondelis®)-Pegylated Liposomal Doxorubicin (Caelyx®) in Patient With Platinum-sensitive Relapse
Principal investigator Frédéric SELLE, MD
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)®.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by ARCAGY/ GINECO GROUP.