Clinical trial · Interventional
Robotic Compared to Fixed Gantry Radiosurgery for Brain Metastases
A Randomized Trial of Robotic Compared to Fixed Gantry Radiosurgery for Brain Metastases
NCT01353573CI-TRIAL-00004823TRICKunknownPhase 3ClinicalTrials.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)
Radiosurgery is precisely delivered high dose radiation. It can be performed using multiple cobalt sources, a modified traditional gantry-based linear accelerator or a robotic linear accelerator. The treatment of brain metastases represents the most common indication for radiosurgery while new indications for this technology are continually being discovered. With the increasing importance of radiosurgery and the resource implications for radiotherapy programs the investigators have proposed the first direct technological comparison of robotic to linear accelerator radiosurgery for 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 |
|---|---|---|---|
| Metastatic Malignant Neoplasm to the Adult Brain | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fixed Gantry Radiosurgery | Radiation | — | UNRESOLVED |
| Robotic Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Fixed Gantry Radiosurgery
- description
- Single fraction radiosurgery will be prescribed using a Fixed Gantry Linear Accelerator
- interventionNames
- Radiation: Fixed Gantry Radiosurgery
- type
- EXPERIMENTAL
- label
- Robotic Radiosurgery
- description
- Single fraction radiosurgery will be prescribed using a robotic linear accelerator
- interventionNames
- Radiation: Robotic Radiosurgery
Primary outcomes (1)
- measure
- Radiosurgery planning and delivery time
- timeFrame
- 14 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1-3 brain metastases from a confirmed primary extra-cranial site Exclusion Criteria: * Any brain metastasis \>3cm in maximal diameter * Easter Cooperative Oncology Group (ECOG) performance status \>2 * Prior surgical resection or radiosurgery of a brain metastasis * Lesion causing significant mass effect (\>1cm midline shift) * Lesion located \<5mm from optic chiasm or within the brainstem * Requires more than one fraction of radiosurgery * Primary disease histology unknown, lymphoma or germ cell tumor
References
Publications (7)
- BACKGROUNDBoudreau R, Clark M, Nkansah E. TomoTherapy, GammaKnife and CyberKnife Therapies for Patients with Tumours of the Lung, Central Nervous System, or Intra-abdomen: A Systematic Review of Clinical Effectiveness and Cost Effectiveness. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2009.
- BACKGROUNDGaspar LE, Mehta MP, Patchell RA, Burri SH, Robinson PD, Morris RE, Ammirati M, Andrews DW, Asher AL, Cobbs CS, Kondziolka D, Linskey ME, Loeffler JS, McDermott M, Mikkelsen T, Olson JJ, Paleologos NA, Ryken TC, Kalkanis SN. The role of whole brain radiation therapy in the management of newly diagnosed brain metastases: a systematic review and evidence-based clinical practice guideline. J Neurooncol. 2010 Jan;96(1):17-32. doi: 10.1007/s11060-009-0060-9. Epub 2009 Dec 4. PMID 19960231
- RESULTRegis J, Tamura M, Guillot C, Yomo S, Muraciolle X, Nagaje M, Arka Y, Porcheron D. Radiosurgery with the world's first fully robotized Leksell Gamma Knife PerfeXion in clinical use: a 200-patient prospective, randomized, controlled comparison with the Gamma Knife 4C. Neurosurgery. 2009 Feb;64(2):346-55; discussion 355-6. doi: 10.1227/01.NEU.0000337578.00814.75. PMID 19190462
- RESULTWowra B, Muacevic A, Tonn JC. Quality of radiosurgery for single brain metastases with respect to treatment technology: a matched-pair analysis. J Neurooncol. 2009 Aug;94(1):69-77. doi: 10.1007/s11060-009-9802-y. Epub 2009 Feb 1. PMID 19184641
- RESULTBlonigen BJ, Steinmetz RD, Levin L, Lamba MA, Warnick RE, Breneman JC. Irradiated volume as a predictor of brain radionecrosis after linear accelerator stereotactic radiosurgery. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):996-1001. doi: 10.1016/j.ijrobp.2009.06.006. Epub 2009 Sep 23. PMID 19783374
- RESULTGwak HS, Yoo HJ, Youn SM, Lee DH, Kim MS, Rhee CH. Radiosurgery for recurrent brain metastases after whole-brain radiotherapy : factors affecting radiation-induced neurological dysfunction. J Korean Neurosurg Soc. 2009 May;45(5):275-83. doi: 10.3340/jkns.2009.45.5.275. Epub 2009 May 31.