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 @ 5:12 AM
Ignite Modification Date:
2025-12-25 @ 5:12 AM
NCT ID:
NCT01503827
Eligibility Criteria:
Inclusion Criteria:
* 1-3 intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation.
* Life expectancy of at least 6 months
* Aged 18 years or older
* WBRT must begin within 8 weeks of completion of localised treatment and within 4 weeks of randomisation
* Able to have an MRI brain scan with contrast. Estimated Glomerular Filtrate Rate (eGFR) is adequate at the discretion of the radiologist and capable of having gadolinium-containing contrast medium for MRI as per practice guidelines
* Complete localised treatment of all these metastases no more than 6 weeks prior to randomisation
* An Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at randomisation
* CT scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must be within 12 weeks of randomisation
* Serum Lactate Dehydrogenase (LDH) must be = or \< 2 x upper limit of normal
* Able to provide written informed consent
Exclusion Criteria:
* Any untreated intracranial disease
* Any previous intracranial treatment (surgical excision and/or stereotactic irradiation treatment and/or WBRT) prior to this diagnosis of intracranial melanoma
* Evidence of leptomeningeal disease on pre-local treatment MRI scan
* Patients with prior cancers, except:
* Those diagnosed more than five years ago with no evidence of disease recurrence within this time;
* Successfully treated basal cell and squamous cell skin carcinoma;
* Carcinoma in-situ of the cervix
* A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol
* Positive urine pregnancy test for women of childbearing potential within a week of registration onto the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01503827
Study Brief:
Protocol Section:
NCT01503827