Phase I Study of Fractionated Stereotactic Radiation Therapy

There is a lack of prospective trial data and consensus guidelines describing the use of Fractionated Stereotactic Radiation Therapy (FSRT) in the treatment of brain metastases. There has been no prospective dose escalation study performed to date to determine the maximum tolerated dose (MTD) in patients treated with FSRT. Prescription doses in the series described above ranged from 18 Gy to 42 Gy, delivered in 3 to 12 fractions. The results of this study will be used to plan future Phase II/III studies to determine the efficacy of different dose fractionation schedules of FSRT. The investigat

Trial Details

NCT ID
NCT03726359
Phase
PHASE1
Sponsor
Albert Einstein College of Medicine
Status
RECRUITING
Cancer Type
Brain Cancer
Locations (sample)
  • The Bronx, New York, United States

Key Eligibility Criteria

  • Pathologically proven diagnosis of a non-hematological malignancy other than small cell lung cancer within 5 years of registration
  • Intact (unresected) brain metastases measuring ≥3 cm and ≤ 6 cm in largest dimension on gadolinium contrast enhanced MRI obtained within 30 days pr…
  • Prior Whole Brain Radiation Therapy (WBRT) is allowed
  • Age ≥ 18 years

For full eligibility, visit ClinicalTrials.gov.

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