Clinical trial · Interventional
A Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain Metastases
A Phase I Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain
NCT03412812CI-TRIAL-00096977RAD1705completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6 Gy | Radiation | — | UNRESOLVED |
| 7 Gy | Radiation | — | UNRESOLVED |
| 8 Gy | Radiation | — | UNRESOLVED |
| 9 Gy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 2.1-4.0 cm diameter
- description
- Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery. Starting dose level 7 Gy x 5 fractions
- interventionNames
- Radiation: 7 Gy
- Radiation: 8 Gy
- Radiation: 9 Gy
- type
- EXPERIMENTAL
- label
- 4.1-6.0 cm diameter
- description
- Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery. Starting dose level 6 Gy x 5 fractions.
- interventionNames
- Radiation: 6 Gy
- Radiation: 7 Gy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.