Clinical trial · Interventional
Using Intensity Modulated Radiation Therapy (IMRT) for Brain Metastases
Phase I Dose Escalation Trial in Patients With Brain Metastases Using IMRT
NCT00328575CI-TRIAL-00024383completedPhase 1ClinicalTrials.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)
The purpose of this study is to determine if using intensity modulated radiation therapy for brain metastases is safe and will improve local control more than standard whole brain radiation therapy.
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 |
|---|---|---|---|
| Neoplasm Metastasis | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity-Modulated Radiotherapy (IMRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intensity-Modulated Radiotherapy (IMRT)
- description
- Patients with brain metastases will be enrolled in one of three dose levels based on tumor size. For tumor size of 3 cm or less (maximum diameter in any dimension), doses of 47.5Gy, 52.5Gy, and 54.5Gy will be tested. For tumor size of greater than 3 cm (maximum diameter in any dimension), doses of 42.5Gy, 47.5Gy, and 52.5Gy will be tested.
- interventionNames
- Radiation: Intensity-Modulated Radiotherapy (IMRT)
Primary outcomes (1)
- measure
- Unacceptable Acute CNS Toxicity
- timeFrame
- 3 weeks
- description
- The primary endpoint is the frequency of patients developing unacceptable acute CNS toxicity.
Secondary outcomes (1)
- measure
- Dose-Limiting Toxicity (DLT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed malignancy * 2-5 parenchymal brain metastases on magnetic resonance imaging (MRI) with a maximum size of 4 cm * Partial resection allowed. Complete resection allowed only in patients with more than 3 lesions. * Karnofsky Performance Status (KPS) equal to or greater than 60 * Neurologic function equal to or greater than 2 Exclusion Criteria: * Recurrent brain tumors * Major medical or psychiatric illnesses * Metastases in brainstem, midbrain, pons, or medulla * Patients with leukemia or lymphoma
References
Publications (0)
Data not yet available
No reference posted for this study.