Clinical trial · Interventional
Focal Intraoperative Radiotherapy of Brain Metastases
Focal Intraoperative Radiotherapy After Resection of Brain Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Planning to join a prospective multicentric trial after evaluation of 10 first participants
Summary
Brief summary (as posted)
Brain metastases (BM) are the most prevalent tumors of the central nervous system (CNS), with a ratio of 10: 1 in relation to primary tumors. In prospective studies, whole-brain radiotherapy (WBRT) reduced the risk of local recurrence after resection of brain metastases from 46-59% to 10-28%. Furthermore, WBRT reduces the incidence of new metastases and death from disease, but no apparent improvement in overall survival (OS). Due to the potential neurocognitive effects associated with WBRT compared to isolated focal approach, several authors have suggested delaying WBRT and perform focal adjuvant RT after resection of isolated BM. In this context, intraoperative radiotherapy (IORT) in the cavity after resection of BM may be an appealing option. The primary objectives of this study are to evaluate local control (LC) and the control of brain disease (LC associated with the absence of new distant BM) after IORT for one completely resected supratentorial BM in the presence of up to 10 lesions suggestive of BM.
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 Metastases, Adult | — | UNRESOLVED | — |
| Central Nervous System Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative Radiotherapy
- description
- Intraoperative Radiotherapy with a mobile device (Intrabeam, Carl Zeiss AG)
- interventionNames
- Radiation: Intraoperative Radiotherapy
Primary outcomes (2)
- measure
- Local control (LC)
- timeFrame
- 1 year
- description
- Rate of local failure in the surgical cavity
- measure
- Control of Brain Disease (CBD)
- timeFrame
- 1 year
- description
- Rate of control in the brain outside
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Histologically confirmed diagnosis of invasive cancer in the presence of up to 10 lesions suggestive of BM * Indication of resection of single lesion suggestive of BM and evidence of macroscopic complete resection * Patient consent to participate in the study Exclusion Criteria: * Previous cranial radiotherapy * Any kind of antineoplasic systemic treatment for less than 7 days of the procedure * Cavities with proximity \< 10 mm from the brainstem or optical pathway. * Pregnant patients
References
Publications (0)
Data not yet available