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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
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP

Tracking Information
First Submitted Date May 28, 2014
First Posted Date June 16, 2014
Last Update Posted Date September 30, 2020
Actual Study Start Date July 10, 2014
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 13, 2014)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ovarian Cancer Treatment Platinum-sensitive Relapse - Cohort Study (PROSPECTYON)
Official Title Non Interventional Study Dealing With the Use of Trabectedin (Yondelis®)-Pegylated Liposomal Doxorubicin (Caelyx®) in Patient With Platinum-sensitive Relapse
Brief 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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with epithelial ovarian cancer, fallopian tube or peritoneal with treatment receiving in relapse platinum-sensitive
Condition Ovarian Cancer
Intervention Drug: Yondelis®-Caelyx®
Observation of Yondelis®-Caelyx® administration
Other Name: Observation of Yondelis®-Caelyx® administration
Study Groups/Cohorts Yondelis®-Caelyx®-relapse ovarian cancer
Yondelis®-Caelyx®-relapse ovarian cancer
Intervention: Drug: Yondelis®-Caelyx®
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 15, 2016)
101
Original Estimated Enrollment
 (submitted: June 13, 2014)
100
Actual Study Completion Date September 18, 2018
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02163720
Other Study ID Numbers PROSPECTYON (GINECO-OV229)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ARCAGY/ GINECO GROUP
Study Sponsor ARCAGY/ GINECO GROUP
Collaborators PharmaMar
Investigators
Principal Investigator: Frédéric SELLE, MD Hôpital Tenon
PRS Account ARCAGY/ GINECO GROUP
Verification Date September 2020