Clinical trial · Interventional
Intraoperative Radiotherapy in Patients With Brain Metastases
NCT04847284CI-TRIAL-00090698recruitingN/AClinicalTrials.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)
Intraoperative radiotherapy (IORT) is a new alternative for local radiotherapy with the advantages of dose escalation, reduced overall treatment time, and enhanced patient convenience, however the degree of efficacy is unknown, as well as and which is the most efficient dose. The objective of this study is to evaluate the efficacy and safety of IORT in patients with surgical excision of brain metastases at a dose of 20 Gy is at least as effective and safe as other forms of radiation therapy in patients with resection of 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 | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arms
- description
- To determine the efficiency and safety of IORT with low-energy photons to the cavity after resection of brain metastases
- interventionNames
- Radiation: Intraoperative radiotherapy
Primary outcomes (3)
- measure
- Median local progression free survival (lPFS)
- timeFrame
- 6 months from the date of surgery.
- description
- Recurrence within a 0.5 cm margin around the resection cavity, assessed by serial magnetic resonance imaging (MRI scans) and response assessment criteria in neuro-oncology (RANO)
- measure
- Radiation-related acute neurotoxicity
- timeFrame
- 3 months from the date of surgery.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Karnofsky Performance Status ≥ 70 * Newly diagnosed cerebral or cerebellar lesion (contrast enhancing on a T1-weighted MRI scan) amenable to total resection with no dural attachment * Frozen section confirming a metastasis of an extracranial ( Central Nervous System i.e. non-CNS) tumor * Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy) * Adequate birth control Exclusion Criteria: * Leptomeningeal spread and dural attachment (assessed pre- and intraoperatively) * Frozen section reveals primary CNS tumor, lymphoma, SCLC (Small-cell lung cancer) or germinoma * More than one brain metastasis * Psychiatric or social condition potentially interfering with compliance * Contraindication against anesthesia, surgery, MRI and/or contrast agents * Pregnant or breast-feeding women
References
Publications (4)
- RESULTGiordano FA, Brehmer S, Murle B, Welzel G, Sperk E, Keller A, Abo-Madyan Y, Scherzinger E, Clausen S, Schneider F, Herskind C, Glas M, Seiz-Rosenhagen M, Groden C, Hanggi D, Schmiedek P, Emami B, Souhami L, Petrecca K, Wenz F. Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma (INTRAGO): An Open-Label, Dose-Escalation Phase I/II Trial. Neurosurgery. 2019 Jan 1;84(1):41-49. doi: 10.1093/neuros/nyy018. PMID 29528443
- RESULTWeil RJ, Mavinkurve GG, Chao ST, Vogelbaum MA, Suh JH, Kolar M, Toms SA. Intraoperative radiotherapy to treat newly diagnosed solitary brain metastasis: initial experience and long-term outcomes. J Neurosurg. 2015 Apr;122(4):825-32. doi: 10.3171/2014.11.JNS1449. Epub 2015 Jan 23. PMID 25614945
- RESULTCifarelli CP, Brehmer S, Vargo JA, Hack JD, Kahl KH, Sarria-Vargas G, Giordano FA. Intraoperative radiotherapy (IORT) for surgically resected brain metastases: outcome analysis of an international cooperative study. J Neurooncol. 2019 Nov;145(2):391-397. doi: 10.1007/s11060-019-03309-6. Epub 2019 Oct 25. PMID 31654248
- RESULTVargo JA, Sparks KM, Singh R, Jacobson GM, Hack JD, Cifarelli CP. Feasibility of dose escalation using intraoperative radiotherapy following resection of large brain metastases compared to post-operative stereotactic radiosurgery. J Neurooncol. 2018 Nov;140(2):413-420. doi: 10.1007/s11060-018-2968-4. Epub 2018 Aug 9. PMID 30094718