Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02054689 : Fractionated Stereotactic Radiosurgery for Large Brain Metastases
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Male or female patients = 18 years of age

- A life expectancy of at least 12 weeks with a Karnofsky performance status of at least
70 (Appendix II)

- The target lesion(s) can be accurately measured in at least one dimension according to
RECIST

- No prior radiotherapy to the brain

- Previous or concurrent systemic or targeted chemotherapy is allowed.

- Patients must have an extra-cranial primary tumor diagnosis

- Patients will have no more than 3 distinct lesions within the brain.

- At least 1 lesion must be a minimum of 3cm in greatest dimension, no larger than 5cm
which will be treatable by fractionated stereotactic radiosurgery

- The additional lesions will each be treated with single fraction stereotactic
radiosurgery

- Patient may be on steroids or anti-epileptics

- Must be aware of the neoplastic nature of his/her disease and willingly provide
written, informed consent after being informed of the procedure to be followed, the
experimental nature of the therapy, alternatives, potential benefits, side-effects,
risks and discomforts

- Patients do not need a histologically proven diagnosis of brain mets

Exclusion Criteria:

- Symptomatic patients in need of surgery to the "target" lesion

- Four or more newly-diagnosed lesions

- Prior surgical resection of targeted tumor

- Prior WBRT

- Primary brain tumor

- Pregnant or breast-feeding patients

- Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02054689      |      Link to official Clinicaltrials.gov listing
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