Clinical trial · Interventional
Volumetric Modulated Arc Therapy (VMAT) for Brain Metastases
A Phase II Study of Whole Brain Radiotherapy With Simultaneous Integrated Boost Using Volumetric Modulated Arc Therapy for One to Ten Brain Metastases
- 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)
Radiotherapy to the whole brain is standard treatment for cancer that has spread to the brain (brain metastases) as it treats both the metastases that can be seen on scans and the brain metastases that are too small to be seen on scans. This study will use a novel radiotherapy technique, called volumetric modulated arc therapy (VMAT), to treat patients with brain metastases. This technique allows delivery of both a standard radiation dose to the whole brain as well as a higher radiation dose to the brain metastases at the same time. The study will assess the effectiveness of using VMAT in treating brain metastases, and examine its potential side-effects.
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 |
|---|---|---|---|
| whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Whole brain radiotherapy
- description
- whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy
- interventionNames
- Radiation: whole brain radiotherapy (WBRT) and a simultaneous integrated boost (SIB) using volumetric modulated arc therapy
Primary outcomes (1)
- measure
- 3 month treatment response of metastases evaluated using contrast-enhanced MRI scan of brain
- timeFrame
- 3 months post treatment
Secondary outcomes (6)
- measure
- 1-year local control of treated metastases evaluated with contrast-enhanced MRI scan of brain
- timeFrame
- 1 year post-treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 * pathologically confirmed solid malignancy diagnosed within the past 5 years (if the original pathological cancer diagnosis is more than 5 years earlier, a biopsy to confirm metastatic relapse within the past 5 years is required) * 1-10 brain metastases * Maximum diameter of largest metastasis ≤ 3 cm * KPS ≥ 70 * Patient is neurologically stable with or without corticosteroids * Extracranial disease well-controlled (6-month estimated median life expectancy). * Available for regular clinical and imaging follow up * Prior craniotomy permitted Exclusion Criteria: * Require craniotomy to relieve mass effect * Previous cranial radiotherapy * Metastatic germinoma, small cell carcinoma, multiple myeloma, lymphoma or leukaemia. * Chemotherapy administered within one week before radiotherapy or planned within one week after radiotherapy. * Metastases within 0.7 cm of the optic chiasm, brainstem or optic nerves * Brainstem metastases * Systemic lupus erythematosis, scleroderma, or other connective tissue disorders not in remission * Multiple sclerosis * Glomerular Filtration Rate \< 60 ml/minute * Non-small cell lung cancer with liver metastases * Bilirubin \> upper normal limit * AST or ALT \> 2X upper normal limit * Pregnancy * Summed volume of all metastasis PTVs \> 50 cm3
References
Publications (2)
- DERIVEDChan M, Ferguson D, Ni Mhurchu E, Yuan R, Gondara L, McKenzie M, Olson R, Thiessen B, Lalani N, Ma R, Nichol A. Patients with pretreatment leukoencephalopathy and older patients have more cognitive decline after whole brain radiotherapy. Radiat Oncol. 2020 Nov 25;15(1):271. doi: 10.1186/s13014-020-01717-x. PMID 33239056
- DERIVEDNichol A, Ma R, Hsu F, Gondara L, Carolan H, Olson R, Schellenberg D, Germain F, Cheung A, Peacock M, Bergman A, Vollans E, Vellani R, McKenzie M. Volumetric Radiosurgery for 1 to 10 Brain Metastases: A Multicenter, Single-Arm, Phase 2 Study. Int J Radiat Oncol Biol Phys. 2016 Feb 1;94(2):312-21. doi: 10.1016/j.ijrobp.2015.10.017. Epub 2015 Oct 22. PMID 26678660