Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.

Not Applicable

Completed

• Conditions: Brain Metastases; Lung Cancer
• Interventions: Device: GammaKnifeIcon®; Device: GammaKnifePerfexion®; Device: MRI; Device: Efficast®

• Registration Number: NCT02732769
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-30
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-08
• Study First Posted: 2016-04-11
• Primary Completion: 2017-07-27
• Study Completion: 2018-03-21
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group treated by radiosurgery with stereotaxic frame	MRI	Subjects will receive a radiosurgery during a brief hospitalization by LeksellGammaKnifePerfexion® (LGKP)
Group treated by radiosurgery with the thermoformed mask	MRI	Subjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast®
Group treated by radiosurgery with the thermoformed mask	GammaKnifeIcon®	Subjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast®
Group treated by radiosurgery with stereotaxic frame	GammaKnifePerfexion®	Subjects will receive a radiosurgery during a brief hospitalization by LeksellGammaKnifePerfexion® (LGKP)
Group treated by radiosurgery with the thermoformed mask	Efficast®	Subjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast®

Primary Outcome Measures

Name	Time	Method
Evaluation of pain during the hospitalization (3 days)	12 months	Questionary (numeric pain intensity scale)

Secondary Outcome Measures

Name	Time	Method
Evaluation of tumor control at 3 months	12 months	No increase of volume greater than 50% on the MRI
Occurrence of clinical side effects	12 months	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Evaluation of tumor control at 6 months	12 months	No increase of volume greater than 50% on the MRI

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France