Clinical trial · Interventional
Fractionated Stereotactic Radiotherapy vs. Single Session Radiosurgery in Patients With Larger Brain Metastases
Efficacy and Safety of Fractionated Stereotactic Radiotherapy (FSRT) in Comparison to Single Session Radiosurgery in Patients With Larger Brain Metastases (2-4 cm)
NCT03697343CI-TRIAL-00062636unknownPhase 3ClinicalTrials.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)
Phase III trial comparing local control and side effects after fractionated stereotactic radiotherapy and single session radiosurgery in patients with larger brain metastases (2-4 cm)
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 |
|---|---|---|---|
| Cerebral Metastases of Solid Cancers | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fractionated stereotactic radiotherapy | Radiation | — | UNRESOLVED |
| Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and
- description
- Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and no margin as defined by the RTOG 9005
- interventionNames
- Radiation: Radiosurgery
- type
- OTHER
- label
- Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm
- description
- Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm margin
- interventionNames
- Radiation: Fractionated stereotactic radiotherapy
Primary outcomes (1)
- measure
- Time to local progression - TTLP
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years, no upper age limit * Karnofsky Performance Score \> 50 points * Expected Survival \> 3 months * 1-10 cerebral metastases of metastatic solid cancer * Indication for local radiotherapy * Patients must be able to understand the protocol and provide informed consent Exclusion Criteria: * Whole Brain radiotherapy no longer than 6 weeks before the start of stereotactic radiotherapy or planned whole brain radiotherapy after stereotactic radiotherapy * Prior irradiation of the cerebral metastasis that is to be treated in the study * Relevant overlap of prior radiation fields with the metastasis that is to be treated in the study * Metastasis in the brainstem * Contraindication for cerebral MRI * Metastasis that is to be treated in the study can't be visualized in contrast-enhanced T1 MRI sequence * Pregnant or lactating women * Abuse of illicit drugs, alcohol or medication * Patient not able or willing to behave according to protocol * Participation in another clinical trial
References
Publications (0)
Data not yet available
No reference posted for this study.