Stereotactic Radiosurgery (SRS) Dose-Escalation Study for Brain Metastasis (NCT02645487) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Stereotactic Radiosurgery (SRS) Dose-Escalation Study for Brain Metastasis
United States135 participantsStarted 2015-12-18
Plain-language summary
SRS dose escalation for brain metastases in radiation-naïve patients will establish true tolerable doses, which may exceed the current standard doses. This may lead to an improvement in local control, patient survival, and/or quality-of life.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Biopsy-proven non-hematopoietic malignancy, except for small cell lung cancer, germ cell cancer, or unknown primary tumor.
✓. Radiographic evidence by MRI (or by CT scan with CT contrast if ineligible or intolerant of MRI) of brain metastasis. (If patient is unable to tolerate MRI contrast, an MRI without contrast is acceptable if lesions are visible)
✓. All brain metastases must be outside the brain stem (midbrain, pons and medulla).
✓. Patient must have 10 or less brain metastases.
✓. The maximum diameter of any lesion must be less than or equal to 3.0 cm.
✓. Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any targeted agents are allowed provided that:
✓. Age ≥ 18 years.
✓. ECOG Performance Score of 2 or better/Karnofsky Performance Status score of 50-60 or better.
Exclusion criteria
✕. Patients had craniotomy and surgery to the brain within 7 days from the date of SRS.
✕. Patients with leptomeningeal metastasis.
✕. Patients with a contraindication to both MRI (with or without contrast) and CT scan (with contrast)
✕. Patients with life expectancy \< 3 months.
What they're measuring
1
Maximal tolerated doses
Timeframe: 90 days
Trial details
NCT IDNCT02645487
SponsorUniversity of Texas Southwestern Medical Center
. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
✕. Subjects must not be pregnant or nursing at the time of SRS treatment due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.