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

September 28, 2020 updated by: ARCAGY/ GINECO GROUP

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)®.

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France
        • Centre de Radiothérapie et d'Oncologie
      • Amiens, France
        • Clinique de l'Europe
      • Angers, France, 49100
        • ICO Paul Papin
      • Bayonne, France, 64100
        • Hôpital de la Côte Basque
      • Besancon, France
        • Hopital Jean Minjoz
      • Bordeaux, France
        • Clinique Tivoli
      • Bourg-En-Bresse, France
        • Hôpital Fleyriat
      • Brest, France, 29200
        • Hôpital Morvan - Centre Hospitalier Universitaire
      • Chalon Sur Saone, France, 71100
        • Cabinet d'Oncologie - Hôpital Privé Sainte Marie
      • Cholet, France
        • Centre Hospitalier de Cholet
      • Guilherand-granges, France, 07500
        • Hôpital Privé Drôme Ardèche - Clinique Pasteur
      • Le Coudray, France, 28630
        • Hôpital Louis Pasteur
      • Lille, France
        • Centre Oscar Lambret
      • Limoges, France
        • CHU Dupuytren
      • Limoges, France, 87042
        • Centre Hospitalier Universitaire Dupuytren
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Marseille, France
        • Institut Paoli Calmette
      • Mougins, France
        • Centre Azuréen de Cancérologie
      • Nancy, France
        • Centre D'Oncologie de Gentilly
      • Orléans, France
        • Centre Hospitalier Regional
      • Paris, France, 75020
        • Hopital Tenon
      • Poitiers, France, 86021
        • Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie
      • Reims, France
        • Institut Jean Godinot
      • Reims, France, 51100
        • Clinique Courlancy
      • Saint Brieuc, France
        • Clinique Armoricaine de Radiologie
      • Saint Herblain, France, 44805
        • ICO Centre René Gauducheau
      • Saint Jean, France, 31240
        • Clinique de l'Union
      • Saint-cyr-sur-loire, France
        • Clinique de l'Alliance
      • Senlis, France, 60309
        • GHPSO - Site Senlis
      • Strasbourg, France, 67000
        • Centre de Radiothérapie - Clinique Sainte-Anne
      • Toulon, France
        • Clinique Saint Jean
      • Toulouse, France, 31059
        • Institut Claudius Regaud
      • Villejuif, France, 94805
        • Institut de Cancérologie Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with epithelial ovarian cancer, fallopian tube or peritoneal with treatment receiving in relapse platinum-sensitive

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Yondelis®-Caelyx®-relapse ovarian cancer
Drug: Yondelis®-Caelyx®
Observation of Yondelis®-Caelyx® administration
Other Names:
  • Observation of Yondelis®-Caelyx® administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Patient will be followed during 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at baseline
Characteristics of the population registered
Time Frame: at baseline
Describe the population that will be registered
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
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
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.
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.

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
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.
during treatment and follow up period (maximum of 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Collaborators

PharmaMar

Investigators

  • Principal Investigator: Frédéric SELLE, MD, Hopital Tenon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

September 18, 2018

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 16, 2014

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROSPECTYON (GINECO-OV229)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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