Clinical trial · Interventional
Whole Brain Radiotherapy Versus Volumetric Modulated Arc Therapy for Brain Metastases
A Randomized Phase II Study of 20 Gy in 5 Fractions Whole Brain Radiotherapy Versus 15 Gy in 1 Fraction Volumetric Modulated Arc Therapy for One to Ten Brain Metastases
NCT02220491CI-TRIAL-00045178AmadeuscompletedN/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)
Patients with brain metastases with expected life expectancy of 3-6 months are typically treated with radiotherapy to the whole brain giving a dose of 20 Gy over a 5 day period. This study will compare this with volumetric modulated arc therapy (VMAT) which is capable of delivering 15 Gy in one single session to identified disease within the brain but sparing the normal surrounding brain tissue. Primarily the study will assess whether it is possible to recruit sufficient patient numbers to a trial of this type. It will also compare effectiveness, side effects and quality of life between the two treatment methods.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single-fraction radiotherapy | Radiation | — | UNRESOLVED |
| Whole-brain radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Whole-brain radiotherapy
- description
- All subjects will have a non-contrast CT scan using a slice thickness of 2.5mm or less. The Brain contour will be generated using the segmentation wizard and edits as required. PTV\_Brain is an expansion of the Brain by 5mm. 99% of PTV\_Brain is to be covered by 95% of 20 Gy in 5 fractions using 6-10 MV photons in a parallel-opposed pair lateral beam arrangement.
- interventionNames
- Radiation: Whole-brain radiotherapy
- type
- EXPERIMENTAL
- label
- Single-fraction radiotherapy
- description
- Immobilized in the mask, the subject will be imaged for radiotherapy planning with a CT slice thickness of 1.25 mm or less and an axial resolution of \< 0.7 mm (CT field of view \< 35 cm). Subjects that require contrast with GFR 45-59 will have pre-hydration, contrast dose modification and/or Mucomyst administration to preserve renal function, according to standard practice for radiological imaging at the institution.
- interventionNames
- Radiation: Single-fraction radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 * Pathologically confirmed solid malignancy * 1-10 brain or brainstem metastases on MRI with a maximum of 4 cm diameter * Documented extracranial disease * Anticipated median survival 3-6 months (Graded Prognostic Assessment: Appendix I) * Available for regular clinical and imaging follow up (\< 1 hour from a cancer centre) * Montreal Cognitive Assessment score ≥ 20 (Appendix II) * Karnofsky Performance Score (KPS) ≥ 70 (Appendix III) * Barthel Activities of Daily Living score ≥ 90 (Appendix IV) * Able to complete EORTC quality of life questionnaires (Appendix V) Exclusion Criteria: * A metastasis located within 5 mm of the optic nerves or optic chiasm * Requiring craniotomy to relieve mass effect * Cytotoxic systemic therapy administered within one week before radiotherapy or planned within one week after radiotherapy * Neurological decline since starting corticosteroids * Metastatic germinoma, small cell carcinoma, multiple myeloma, lymphoma or leukaemia * Systemic lupus erythematosis, scleroderma, or other connective tissue disorders not in remission * Multiple sclerosis * Glomerular Filtration Rate \< 45 ml/minute * Contra-indications to MRI * Pregnancy * AST, ALT or Bilirubin \> 3 times upper limit of normal * Haemorrhagic Metastases
References
Publications (21)
- BACKGROUNDMekhail T, Sombeck M, Sollaccio R. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. Curr Oncol Rep. 2011 Aug;13(4):255-8. doi: 10.1007/s11912-011-0180-1. No abstract available. PMID 21584645
- BACKGROUNDSoon YY, Tham IW, Lim KH, Koh WY, Lu JJ. Surgery or radiosurgery plus whole brain radiotherapy versus surgery or radiosurgery alone for brain metastases. Cochrane Database Syst Rev. 2014 Mar 1;2014(3):CD009454. doi: 10.1002/14651858.CD009454.pub2. PMID 24585087
- BACKGROUNDSoffietti R, Kocher M, Abacioglu UM, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Mueller RP, Tridello G, Collette L, Bottomley A. A European Organisation for Research and Treatment of Cancer phase III trial of adjuvant whole-brain radiotherapy versus observation in patients with one to three brain metastases from solid tumors after surgical resection or radiosurgery: quality-of-life results. J Clin Oncol. 2013 Jan 1;31(1):65-72. doi: 10.1200/JCO.2011.41.0639. Epub 2012 Dec 3. PMID 23213105
- BACKGROUNDChang EL, Wefel JS, Hess KR, Allen PK, Lang FF, Kornguth DG, Arbuckle RB, Swint JM, Shiu AS, Maor MH, Meyers CA. Neurocognition in patients with brain metastases treated with radiosurgery or radiosurgery plus whole-brain irradiation: a randomised controlled trial. Lancet Oncol. 2009 Nov;10(11):1037-44. doi: 10.1016/S1470-2045(09)70263-3. Epub 2009 Oct 2. PMID 19801201
- BACKGROUNDRodrigues G, Warner A, Zindler J, Slotman B, Lagerwaard F. A clinical nomogram and recursive partitioning analysis to determine the risk of regional failure after radiosurgery alone for brain metastases. Radiother Oncol. 2014 Apr;111(1):52-8. doi: 10.1016/j.radonc.2013.11.015. Epub 2014 Jan 17. PMID 24444529
- BACKGROUNDTsao MN, Lloyd N, Wong RK, Chow E, Rakovitch E, Laperriere N, Xu W, Sahgal A. Whole brain radiotherapy for the treatment of newly diagnosed multiple brain metastases. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD003869. doi: 10.1002/14651858.CD003869.pub3.