Phase I Study of Fractionated Stereotactic Radiation Therapy
ConditionBrain Metastases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbert Einstein College of Medicine
About this trial
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 investigator team thus proposes a Phase I study to determine the feasibility and safety of FSRT in patients with brain metastases.
Eligibility criteria
Qualifiers
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 prior to registration OR Surgically resected brain metastasis for which postoperative stereotactic radiotherapy is indicated, with expected target measuring ≥3 cm and ≤6 cm in largest dimension
Prior Whole Brain Radiation Therapy (WBRT) is allowed
Age ≥ 18 years
Disqualifiers
Patients with definitive leptomeningeal metastases, based on cerebrospinal fluid (CSF) examination
Plan for chemotherapy or targeted agents during treatment. Hormonal therapy, immunotherapy targeting PD-1/PD-L1 axis, and bone supportive therapy may be continued during treatment
Contraindication to enhanced MRI imaging such as implanted metal devices. However, patients with implanted devices which are MRI compatible are allowed
Patients with measurable brain metastasis resulting from small cell lung cancer and germ cell malignancy
Trial design
Treatments tested in this trial
- Fractionated Stereotactic Radiation Therapy (FSRT)
Treatment groups
43 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov