Clinical trial · Interventional
Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases
A Phase I/II Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases
NCT00928226CI-TRIAL-00073398completedN/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 maximum tolerated dose of 3-session (ie, treatment) stereotactic radiosurgery (SRS) to treat brain metastases greater than 4.2 cm³ in size will be determined. This study investigates if increasing radiation dose improves outcome for patients without greater toxicity (side effects).
Conditions
Conditions (4)
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 |
| Cancer of Brain and Nervous System | — | UNRESOLVED | — |
| Metastatic Malignant Neoplasm to Brain | — | UNRESOLVED | — |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fractionated Stereotactic Radiosurgery (SRS) | Radiation | — | UNRESOLVED |
| Surgical resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm 1 - 24 Grey SRS
- description
- 24 Grey administered as 8 Gy x 3 fractions
- interventionNames
- Radiation: Fractionated Stereotactic Radiosurgery (SRS)
- Procedure: Surgical resection
- type
- EXPERIMENTAL
- label
- Arm 2 - 27 Grey SRS
- description
- 27 Grey administered as 9 Gy x 3 fractions
- interventionNames
- Radiation: Fractionated Stereotactic Radiosurgery (SRS)
- Procedure: Surgical resection
- type
- EXPERIMENTAL
- label
- Arm 3 - 30 Grey SRS
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA * Age 18 years and older * Pathologically-proven solid tumor malignancy * 1 to 4 brain metastases, one of which is 4.2 to 33.5 cm³. * Prior surgery or SRS is allowed as long as the target metastatic lesion in this study has not previously been treated with SRS. * Prior cytotoxic systemic therapy must be completed ≥ 5 days prior to radiosurgery. No concurrent cytotoxic systemic therapy along with SRS. Cytotoxic systemic therapy to start ≥ 5 days after the completion of SRS. * Life expectancy of ≥ 12 weeks. * Ability to understand and the willingness to sign a written informed consent. EXCLUSION CRITERIA * Previously treated with whole brain irradiation * Target metastatic lesion previously been treated with SRS. * \> 4 total brain metastases at the time of initial evaluation. * Pregnant * Unable to give informed consent.
References
Publications (1)
- DERIVEDRahimy E, Dudley SA, von Eyben R, Pollom EL, Seiger K, Modlin L, Wynne J, Fujimoto D, Jacobs LR, Chang SD, Gibbs IC, Hancock SL, Adler JR, Li G, Choi CYH, Soltys SG. Phase I/II Dose-Escalation Trial of 3-Fraction Stereotactic Radiosurgery for Resection Cavities From Large Brain Metastases: Health-related Quality of Life Outcomes. Am J Clin Oncol. 2021 Nov 1;44(11):588-595. doi: 10.1097/COC.0000000000000868. PMID 34670228