Clinical trial · Interventional
Optimal Planning Target Volume With Stereotactic Radiosurgery
Determination of the Optimal Planning Target Volume for Brain Metastases Treated With Stereotactic Radiosurgery
NCT01017497CI-TRIAL-00016866completedN/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)
The purpose of this study is to estimate the rate of local control at the treated site of the metastasis as a function of 1mm versus 3mm expansion about the gross tumor volume (GTV). Each lesion, not each patient will be ranndomized to either the 1mm or 3mm margin with 40 lesions randomized to each arm.
Conditions
Conditions (2)
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 Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1mm margin
- description
- GTV expanded by 1 mm
- interventionNames
- Radiation: Stereotactic Radiosurgery
- type
- EXPERIMENTAL
- label
- 3mm margin
- description
- GTV expanded by 3 mm
- interventionNames
- Radiation: Stereotactic Radiosurgery
Primary outcomes (1)
- measure
- 12-month Local Control Rate
- timeFrame
- 12 months after SRS
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Life expectancy of at least 6 months. * Karnofsky Performance Score greater than 70 * Graded prognostic assessment (GPA score 0.5 or greater * 1 to 3 brain metastases unresectable * Maximum tumor diameter no larger than 4cm Exclusion Criteria: * Primary lesion with radiosensitive histology (such as: small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma. * Metastases in the brain stem, pons or medulla or within 5 mm of optic apparatus * Previous cranial radiation * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.