NCT03303365: CYBER-SPACE

Cyberknife Radiosurgery for Patients With Brain Metastases Diagnosed With Either SPACE or MPRAGE Sequence

Completed NA Last updated 3 November 2022

What this trial tests

NA trial testing stereotactic radiosurgery (SRS) in Brain Metastases in 203 participants. Completed in 1 June 2021.

Timeline

1 February 2018

Primary endpoint
1 June 2021

1 June 2021

Quick facts

Lead sponsor	Juergen Debus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	203
Start date	1 February 2018
Primary completion	1 June 2021
Estimated completion	1 June 2021
Sites	1 location across Germany

Drugs / interventions tested

• stereotactic radiosurgery (SRS)

Conditions studied

• Brain Metastases — all drugs for Brain Metastases →
• Adult Solid Tumor — all drugs for Adult Solid Tumor →

Sponsor

Juergen Debus

Who can join

18 and older, any sex, with Brain Metastases or Adult Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

For patients with cerebral oligometastases who are in adequate clinical condition stereotactic radiosurgery (SRS) is the treatment of choice, being recommended by international guidelines for the treatment of one to four lesions. Newer findings have shown that for patients with more than four lesions SRS can be considered as a favorable alternative to whole-brain radiotherapy (WBRT), the currently established standard-of-care treatment. With modern techniques highly conformal SRS of multiple lesions has become feasible with comparable clinical effort and minimal toxicity as compared to WBRT. Developments in magnetic resonance imaging (MRI- imaging) have produced highly sensitive contrast-enhanced three-dimensional fast spin echo sequences such as SPACE that facilitate the detection of very small and early-stage lesions in a fashion superior to the established Magnetization Prepared Rapid Gradient Echo (MPRAGE) series.

Since it has been established that the response of brain metastases to SRS is better for smaller lesions and that WBRT can come at the price of significant neurotoxicity, the investigators hypothesize that 1) earlier detection of small brain metastases and 2) early and aggressive treatment of those by SRS will result in an overall clinical benefit by delaying the failure of repeated localized therapy and thus preserving quality of life and potentially prolonging overall survival. On the other hand however, overtreatment might be a valid concern with this approach since it has yet to be proved that a clinical benefit can be achieved.

The current study aims to stretch the boundaries of the term "cerebral oligometastases" by performing SRS for up to ten cerebral metastases, compared to the established clinical standard of four, given that existing data supports the non-inferiority of this approach and given that modern Cyberknife SRS facilitates the treatment of multiple lesions with minimal treatment-associated toxicity.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cognitive effects of stereotactic radiosurgery in adult patients with brain metastases: A systematic review.
   Schimmel WCM, Gehring K, Eekers DBP, Hanssens PEJ, et al · · 2018 · cited 18× · PMID 30370357 · DOI 10.1016/j.adro.2018.06.003
2. Preservation of neurocognitive function in the treatment of brain metastases.
   Parsons MW, Peters KB, Floyd SR, Brown P, et al · · 2021 · cited 16× · PMID 34859237 · DOI 10.1093/noajnl/vdab122
3. Stereotactic radiosurgery for 1-10 brain metastases to avoid whole-brain radiotherapy: Results of the CYBER-SPACE randomized phase 2 trial.
   El Shafie RA, Bernhardt D, Welzel T, Schiele A, et al · · 2025 · cited 10× · PMID 39340439 · DOI 10.1093/neuonc/noae201
4. Stereotactic radiotherapy of brain metastases: clinical impact of three-dimensional SPACE imaging for 3T-MRI-based treatment planning.
   Welzel T, El Shafie RA, V Nettelbladt B, Bernhardt D, et al · · 2022 · cited 8× · PMID 35976408 · DOI 10.1007/s00066-022-01996-1
5. Enhancing deep learning methods for brain metastasis detection through cross-technique annotations on SPACE MRI.
   Wald T, Hamm B, Holzschuh JC, El Shafie R, et al · · 2025 · cited 2× · PMID 39913077 · DOI 10.1186/s41747-025-00554-5