We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases (PRAMECE-1302) (PRAMECE-1302)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Centre Oscar Lambret.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02565433
First Posted: October 1, 2015
Last Update Posted: October 1, 2015
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.
Collaborator:
Centre Hospitalier Universitaire de Besancon
Information provided by (Responsible Party):
Centre Oscar Lambret
  Purpose
The aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases.

Condition Intervention
Neoplasm Metastases Other: questionnaire administration

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Impact at 6 months of the radiosurgery based on the evaluation of 4 criteria of the QLQ C30 questionnaire [ Time Frame: 6 months ]
    The 4 criteria are the perceived overall state, health, physical functioning, cognitive functioning and tiredness


Secondary Outcome Measures:
  • Comparison of the scores obtained on the scales, questionnaires and Performance status at baseline and every 3 months (until 12 months) after Gamma Knife treatment [ Time Frame: 1 year ]
    QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition), ESAS (quality of life), Performance status (OMS)

  • Comparison of the scores obtained on the scales and questionnaires according to the type of primary cancer at baseline and every 3 months (until 12 months) after Gamma Knife treatment [ Time Frame: 1 year ]
    QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition)

  • Comparison of the scores obtained on different scales according to the type of associated treatments at baseline and every 3 months (until 12 months) after Gamma Knife treatment [ Time Frame: 1 year ]

    The type of associated treatments are: chemotherapy, targeted therapy, corticoids, anti-epileptics, psychotropic drugs.

    The different scales are QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), ESAS (quality of life) and MoCA (cognition)


  • Correlation between the scores obtained on the different scales at the baseline and the progression-free survival / overall survival [ Time Frame: 1 year ]
  • Correlation between the scores obtained on the scales QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition), ESAS (quality of life) at baseline and those obtained at 3, 6, 9, 12 months [ Time Frame: 1 year ]
  • Correlation between the scores obtained on the scales during the study and the clinical neurological response at baseline and every 3 monts until 12 months after Gamma Knife treatment [ Time Frame: 1 year ]
    The correlation will take into account the evolution of the systemic disease and the volumetric tumor response. Volumetric tumor responses will be calculated on the MRI's


Estimated Enrollment: 130
Study Start Date: November 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: questionnaire administration
Quality of life questionnaires administration (EORTC QLQ C30 and BN20 / IADL / HADS / MoCa Edmonton Symptom Assessment Scale)
Other: questionnaire administration
Within 15 days before radiosurgery and then at 3, 6, 9, 12 months after radiosurgery, the patients who have accepted to participate will have to complete these questionnaires : QLQC30, BN20, IADL, HADS, MoCa, Edmonton Symptom Assessment Scale
Other Name: survey administration

Detailed Description:
The patients who meet the selection criteria and who have accepted to participate at the study will answer different questionnaires of the study before radiosurgery and at 3, 6, 9 and 12 months after the treatment of brain metastases. Baseline examinations will be done before receiving the treatment during the hospitalisation for the Gamma Knife treatment, and then they will be repeated at the evaluation visits which are classically done every 3 months. MRI's will also be performed every 3 months. In this way, no additional travel or MRI will be carried out as part of the study.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with newly diagnosed brain metastases
  • Patient with cancer regardless of the type of primary cancer, with anatomopathological proof
  • At least, one measurable lesion ≥ 10 mm on the MRI T1 gadolinium sequences
  • Number of brain metastases lower or equal to 5
  • Indication of radiosurgery treatment
  • Age ≥ 18 years old
  • ECOG-PS 0-2
  • Expected survival > 3 months
  • Ability to complete self-administered questionnaires. If the patient has a motor disability (hemibody deficit) that does not allow to complete himself the questionnaires, these will be read by a CRA of the Neurosurgery department who will outline the questions without making any comment.
  • A non-opposition form must have been completed by the patient

Exclusion Criteria:

  • Previous cancer (< 5 years) except of carcinoma of cervix uteri, basal cell or squamous cell skin carcinoma adequately treated
  • Previous brain radiotherapy
  • Neurological pathology with cognitive disorders existing before the study
  • Having a contraindication for MRI
  • Associated leptomeningeal disease
  • Patients having another severe or uncontrolled pathology which could compromise the participation at the study (such as infection, cardiovascular, digestive, renal or pulmonary disease)
  • Pregnant or breastfeeding woman. The women must not breastfeed for at least 6 months
  • Impossibility to submit to the medical examinations of the study due to geographic, social or mental reasons
  Contacts and Locations
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): NCT02565433


Contacts
Contact: Emilie Le Rhun, MD +33 3 20 44 65 42 E-lerhun@o-lambret.fr

Locations
France
CHRU de Lille - Hôpital Salengro Recruiting
Lille, France, 59037
Contact: Emilie Le Rhun, MD    +33 3 20 44 65 42    E-lerhun@o-lambret.fr   
Contact: François Dubois, MD    +33 3 20 44 65 42      
Principal Investigator: Emilie Le Rhun, MD         
Sub-Investigator: François Dubois, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Centre Hospitalier Universitaire de Besancon
Investigators
Principal Investigator: Emilie Le Rhun, MD Centre Oscar Lambret
Study Director: Franck Bonnetain, MD CHRU de Besançon
  More Information

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT02565433     History of Changes
Other Study ID Numbers: PRAMECE-1302
First Submitted: May 19, 2015
First Posted: October 1, 2015
Last Update Posted: October 1, 2015
Last Verified: September 2015

Keywords provided by Centre Oscar Lambret:
brain metastases
Gamma Knife
Radiosurgery
Quality of Life

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes