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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 : November 9, 2018
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP

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.

Condition or disease Intervention/treatment
Ovarian Cancer Drug: Yondelis®-Caelyx®

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)®.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
Yondelis®-Caelyx®-relapse ovarian cancer
Yondelis®-Caelyx®-relapse ovarian cancer
Drug: Yondelis®-Caelyx®
Observation of Yondelis®-Caelyx® administration
Other Name: Observation of Yondelis®-Caelyx® administration




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with epithelial ovarian cancer, fallopian tube or peritoneal with treatment receiving in relapse platinum-sensitive
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.

Information from the National Library of Medicine

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


Locations
Show Show 33 study locations
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
PharmaMar
Investigators
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Principal Investigator: Frédéric SELLE, MD Hôpital Tenon
Additional Information:

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Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT02163720    
Other Study ID Numbers: PROSPECTYON (GINECO-OV229)
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Keywords provided by ARCAGY/ GINECO GROUP:
ovarian cancer
fallopian tube or primary peritoneal
relapse
platinum-sensitive
Yondelis®-Caelyx®
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hypersensitivity
Recurrence
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes
Immune System Diseases
Liposomal doxorubicin
Doxorubicin
Trabectedin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents