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.]

NCT01046123 : Volumetric Modulated Arc Therapy (VMAT) for Brain Metastases
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Age ? 18

- pathologically confirmed solid malignancy diagnosed within the past 5 years (if the
original pathological cancer diagnosis is more than 5 years earlier, a biopsy to
confirm metastatic relapse within the past 5 years is required)

- 1-10 brain metastases

- Maximum diameter of largest metastasis ? 3 cm

- KPS ? 70

- Patient is neurologically stable with or without corticosteroids

- Extracranial disease well-controlled (6-month estimated median life expectancy).

- Available for regular clinical and imaging follow up

- Prior craniotomy permitted

Exclusion Criteria:

- Require craniotomy to relieve mass effect

- Previous cranial radiotherapy

- Metastatic germinoma, small cell carcinoma, multiple myeloma, lymphoma or leukaemia.

- Chemotherapy administered within one week before radiotherapy or planned within one
week after radiotherapy.

- Metastases within 0.7 cm of the optic chiasm, brainstem or optic nerves

- Brainstem metastases

- Systemic lupus erythematosis, scleroderma, or other connective tissue disorders not
in remission

- Multiple sclerosis

- Glomerular Filtration Rate < 60 ml/minute

- Non-small cell lung cancer with liver metastases

- Bilirubin > upper normal limit

- AST or ALT > 2X upper normal limit

- Pregnancy

- Summed volume of all metastasis PTVs > 50 cm3
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01046123      |      Link to official Clinicaltrials.gov listing
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