Clinical trial · Observational
Local Ablative Therapy for Patients With Multiple (4-10) Brain Metastases
NCT04397978CI-TRIAL-00078425LAT-MUMunknownClinicalTrials.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)
To observe the quality of life (QOL) and to report on toxicity and outcome parameters after the (repeated) use of local ablative therapy (LAT) i.e. stereotactic radiotherapy (SRT) for patients with multiple (4-10) brain metastases
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 |
|---|---|---|---|
| Brain Metastases, Adult | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Quality of life
- timeFrame
- From baseline to 3 month after radiotherapy
- description
- Measured by the EQ-5D-5L questionnaire
- measure
- Quality of life
- timeFrame
- From baseline to 3 month after radiotherapy
- description
- Measured by the QLQ-BN20 questionnaire
- measure
- Quality of life
- timeFrame
- From baseline to 3 month after radiotherapy
- description
- Measured by the PRO-CTCAE
Secondary outcomes (9)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female, ≥ 18 years of age 2. Minimal 4 and up to a maximum of 10 synchronous BM diagnosed on a high resolution contrast-enhanced MRI scan (T1 gadolinium) not dated more than 4 weeks prior to inclusion. 3. Maximal lesion diameter of single gross tumor volume (GTV) of 3 cm 4. Maximal cumulative GTV (+CTV for cavity) of 30cm3 5. Karnofsky performance status ≥ 70 6. DS-GPA or expected overall survival (if no DS-GPA applicable) of ≥ 1.5 or \>3 months respectively. 7. Any solid primary tumour. Lymphoma, germ cell tumor, small cell lung carcinoma and multiple myeloma are excluded. 8. Ability to provide written informed consent and to participate in the procedure of the questionnaires. Exclusion Criteria: 1. BM not amenable to SRT 2. Previous SRT or surgery on the same lesion 3. Co-morbidities considered clinically precluding the safe use of an MRI examination or SRT 4. Any psychological, sociological or geographical issue potentially hampering compliance with the study 5. Pregnancy 6. Concurrent use of systemic therapy 7. More than 10 BM on planning-MRI 8. Maximum cumulative GTV (+CTV for cavity) of more than 30cm3 on planning-MRI 9. A brainstem metastasis with a PTV of more than 20 cm3 10. Leptomeningeal disease
References
Publications (0)
Data not yet available
No reference posted for this study.