N/A
Completed N=13
A Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain Metastases
Source: ClinicalTrials.gov NCT03412812 ↗Enrolled (actual)
13
Serious AEs
53.8%
Results posted
May 2025
Primary outcomePrimary: Maximum Tolerated Dose of Five Fraction Stereotactic Radiotherapy — 35; 30 Gy
Summary
This study looks at dose escalation for five fraction stereotactic radiotherapy for patients diagnosed with brain metastases with tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose of Five Fraction Stereotactic Radiotherapy |
35; 30 | — |
| SECONDARY Acute Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire |
— | — |
| SECONDARY Late Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire |
— | — |
| SECONDARY Rate of Local Tumor Control With Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire |
— | — |
Eligibility Criteria
Inclusion Criteria
- All patients must have histologically confirmed malignancy.
- All patients must have imaging suggestive of one or more brain metastases.
- Karnofsky performance status (KPS) ≥ 60
- Age > 18 years
- Patients must provide written informed consent to participate in the study.
- Patients must have less than or equal to 10 brain metastases as identified on brain MRI.
Exclusion Criteria
- History of surgical resection to the tumor of interest
- History of radiation to the tumor of interest
- History of previous whole brain irradiation
- Receipt of systemic therapy within one week of planned radiation treatment except for hormonal agents.
- Patient is unable to have MRI or MRI contrast.
- Inability to meet the appropriate normal tissue dose constraints secondary to tumor location should result in exclusion of the patient / tumor.
- Patients with a non-index tumor (second tumor) greater than 3 cm in diameter will be excluded.
Data sourced from ClinicalTrials.gov (NCT03412812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.