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Completed

NCT Number: NCT02163720

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre de Radiothérapie et d'Oncologie, Agen, France

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About this study

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)®.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yondelis®-Caelyx®

Drug

Observation of Yondelis®-Caelyx® administration

Other names: Observation of Yondelis®-Caelyx® administration

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. Characteristics of the population registered

    Time frame: at baseline

    Describe the population that will be registered

  3. 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)

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Collaborators

  • PharmaMar

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jun 16, 2014
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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