Phase I Study of Fractionated Stereotactic Radiation Therapy
ConditionBrain Metastases
Trial statusRecruiting
Trial phaseNot applicable
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Fractionated Stereotactic Radiation Therapy (FSRT)
RadiationInitial starting dose will be 7 Gy x5= 35 Gy delivered to the planning target volume (PTV). Radiotherapy will be delivered every other day so that the Stereotactic Body Radiation Therapy (SBRT) schedule is completed within 1.5-2 weeks.
Treatment groups
43 Participants
are divided into 1 treatment groupGroup A: Fractionated Stereotactic Radiation Therapy (FSRT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Tolerated Dose (MTD)
Determine the maximum tolerated dose (MTD) associated with a 20% probability of dose limiting toxicity (DLT). DLT is defined as grade 3 or higher toxicities (per CTCAE version 4.03; MedDRA version 12.0) that occur within 1 year of treatment start and are either possibly, probably, or definitively related to radiotherapy (RT), and related to the specific symptoms.
Time frame
Within 1 year of initiation of treatmentSecondary outcomes
1
Response to Treatment
Response to treatment will be assessed based on the percentage of patients who achieve either a complete response (CR), partial response (PR), or stable disease (SD), or progression (P) in response to FSRT treatment. Best response will be summarized. Response criteria will be assessed as follows: Complete Response (CR): Defined as follow up imaging which shows that complete radiographic disappearance of brain metastasis Partial Response (PR): Decrease of \>50% in the size of each lesion radiographically, using perpendicular diameters Stable Disease (SD): 0 to 50% reduction in size of each lesion radiographically, using perpendicular diameters Progression (P): Defined as \> 25% increase in the size of each lesion or a new, non-contiguous lesion developed outside of the radiosurgical volume
Time frame
Up to 1 year following initiation of treatmentSponsors and contacts
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Source ClinicalTrials.gov