Clinical trial · Interventional
Exclusive Hypofractionated Stereotactic Radiotherapy in Non-resectable Single Brain Metastasis
Exclusive Hypofractionated Stereotactic Radiotherapy in Non-resectable Single Brain Metastasis: Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participants enrolled.
Summary
Brief summary (as posted)
Patients with single brain metastasis without other metastatic site have a better prognosis, and they need a better brain metastasis control. For non-resectable and non-radiosurgical brain metastasis, the gold standard treatment is whole-brain irradiation with 30 Gy in 10 fractions, but the local control is not achieved in most of the cases. This study investigate the possibility to increase radiation dose in this metastasis with exclusive hypofractionated stereotactic radiotherapy.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Metastasis | Brain Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hypofractionated stereotactic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- feasibility
- timeFrame
- 1 year
- description
- Through this study we prospectively evaluate the alternative of performing exclusive hypofractionated stereotactic radiotherapy for patients with single brain metastasis that is not eligible for surgery or radiosurgery, with a good prognosis for survival and lower risk of metachronous brain metastases, the primary objective being to verify whether the treatment is feasible in clinical practice.
Secondary outcomes (1)
- measure
- survival
- timeFrame
- 1 year
- description
- As a secondary objective, we will evaluate local control, tumor reduction, quality of life, overall survival, whole-brain irradiation free survival and acute and late toxicities related to treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathology of primary tumors: all but the primary characteristics of melanoma cancer, small cell lung cancer, germ cell tumors, leukemia or lymphoma, or primary central nervous system. * Primary-site: controlled, meaning operated and / or irradiated tumor activity without detectable local * Meningeal dissemination: none * Extra-cranial metastases: none * Pre-irradiation brain: absent * Number of brain metastases: one * Location of brain metastasis: brain regions not eligible for surgery (such as the hippocampus, amygdala, motor area, eloquent cortex, thalamus, hypothalamus, basal ganglia, optic tract, midbrain, pons, medulla, corpus callosum and internal capsule) or radiosurgery( metastasis \<5 mm from the thalamus, hypothalamus, basal ganglia, optic tract, midbrain, pons, medulla, corpus callosum and internal capsule, and / or ≥ 10 ml or ≥ 3 cm in greatest diameter, or 10 ml tissue receiving ≥ 12 Gy). * Karnofsky Performance Status ≥ 70% * Informed consent: authorized Exclusion Criteria: * patients that don't have the eligibility below
References
Publications (0)
Data not yet available