Clinical Trial Details
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NCT03189381 : Pilot Phase 2 Study Whole Brain Radiation Therapy With Simultaneous Integrated Boost for Patients With Brain Metastases
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria

1. Age = 18 at time of consent.

2. Ability to provide written informed consent and HIPAA authorization.

3. Pathological diagnosis of any solid tumor histology (from any site in the body).

4. Pathological or clinical (i.e., by imaging) diagnosis of brain metastatic tumor

5. Total volume of lesions = 30 cm3.

6. Maximum volume of largest lesion = 5 cm3.

a. This volume limit would be equivalent to a largest diameter of about 2.1 cm,
assuming a perfect sphere.

7. Not a candidate for or eligible for but refused Gamma Knife radiosurgery.

Exclusion Criteria

1. Previous radiation to the brain, including WBRT or brain radiosurgery.

2. Life expectancy < 6 months (as estimated per ds-GPA).

3. Inability to comply with treatment per investigator discretion.

4. Inability to complete neurocognitive assessments per investigator discretion.

Of note, tumor lesion number is not an inclusion or exclusion criteria as we are using
volume-based criteria instead.
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