Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT02565433
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02565433
Study Brief:
Protocol Section:
NCT02565433