Back to resultsClinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask. (Mask)
Primary Purpose
Lung Cancer, Brain Metastases
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
GammaKnifePerfexion®
GammaKnifeIcon®
Efficast®
MRI
Sponsored by
About this trial
This is an interventional basic science trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Subject bearing of one to five intellectual metastases of lung origin at the time of the indication of the radiosurgery
- Subject requiring a radiosurgical treatment with LGK
Exclusion Criteria:
- Subject having hurts of the brainstem or para-optics
- Pregnant women or in feeding period
- Subject having received previously a whole brain radiotherapy
Sites / Locations
- Assistance Publique Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group treated by radiosurgery with stereotaxic frame
Group treated by radiosurgery with the thermoformed mask
Arm Description
Subjects will receive a radiosurgery during a brief hospitalization by LeksellGammaKnifePerfexion® (LGKP)
Subjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast®
Outcomes
Primary Outcome Measures
Evaluation of pain during the hospitalization (3 days)
Questionary (numeric pain intensity scale)
Secondary Outcome Measures
Evaluation of tumor control at 3 months
No increase of volume greater than 50% on the MRI
Evaluation of tumor control at 6 months
No increase of volume greater than 50% on the MRI
Occurrence of clinical side effects
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Full Information
NCT ID
NCT02732769
First Posted
March 30, 2016
Last Updated
October 1, 2018
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02732769
Brief Title
Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.
Acronym
Mask
Official Title
Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
July 27, 2017 (Actual)
Study Completion Date
March 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
the Mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years.
This trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and specifically for each step of the procedure. It will also evaluate other parameters such as the effectiveness of these two strategies and tolerance.The expected benefit is an improvement of the comfort for the patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Brain Metastases
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group treated by radiosurgery with stereotaxic frame
Arm Type
Active Comparator
Arm Description
Subjects will receive a radiosurgery during a brief hospitalization by LeksellGammaKnifePerfexion® (LGKP)
Arm Title
Group treated by radiosurgery with the thermoformed mask
Arm Type
Experimental
Arm Description
Subjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast®
Intervention Type
Device
Intervention Name(s)
GammaKnifePerfexion®
Intervention Description
neurosurgery
Intervention Type
Device
Intervention Name(s)
GammaKnifeIcon®
Intervention Description
neurosurgery
Intervention Type
Device
Intervention Name(s)
Efficast®
Intervention Description
Thermoformed mask
Intervention Type
Device
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
Evaluation of pain during the hospitalization (3 days)
Description
Questionary (numeric pain intensity scale)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluation of tumor control at 3 months
Description
No increase of volume greater than 50% on the MRI
Time Frame
12 months
Title
Evaluation of tumor control at 6 months
Description
No increase of volume greater than 50% on the MRI
Time Frame
12 months
Title
Occurrence of clinical side effects
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject bearing of one to five intellectual metastases of lung origin at the time of the indication of the radiosurgery
Subject requiring a radiosurgical treatment with LGK
Exclusion Criteria:
Subject having hurts of the brainstem or para-optics
Pregnant women or in feeding period
Subject having received previously a whole brain radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DESALBRES
Organizational Affiliation
ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.
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