Clinical trial · Interventional
Whole Brain Radiotherapy (WBRT) Versus Stereotactic Radiosurgery (SRS) for 4 Upto 10 Brain Metastases
Whole Brain Radiotherapy vs. Stereotactic Radiosurgery for 4 - 10 Brain Metastases:a Phase III Randomized Multicenter Trial
NCT02353000CI-TRIAL-00045334WBRTvsSRSterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to achieve accrural within anticipated timeframe
Summary
Brief summary (as posted)
Recently stereotactic radiosurgery (SRS) in 5 up to 10 brain metastases showed to have equal survival as in 2 up to 4 brain metastases. Whole brain radiotherapy (WBRT) is currently the gold standard for patients with more than 3 brain metastases, but has significant side effects. In this prospective randomized phase III trial WBRT is compared to SRS for patients with 4 up to 10 BM.
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 |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Radiosurgery | Radiation | — | UNRESOLVED |
| Whole Brain Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stereotactic Radiosurgery
- description
- Stereotactic Radiosurgery for patients with 4 up to 10 brain metastases:
- interventionNames
- Radiation: Stereotactic Radiosurgery
- type
- OTHER
- label
- Whole Brain Radiotherapy
- description
- Whole Brain Radiotherapy for patients with 4 up to 10 brain metastases:
- interventionNames
- Radiation: Whole Brain Radiotherapy
Primary outcomes (1)
- measure
- Quality of life in patients with 4 - 10 brain metastases comparing WBRT and SRS
- timeFrame
- Change in quality of life measured from baseline to 3 months after radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Minimal 4 up to a maximum of 10 BM on diagnostic MRI scan * Max diameter of single GTV 2.5cm * Max cumulative GTV of 30cm3 * Karnofsky performance status ≥ 70 * Any solid primary tumour. Small cell lung carcinoma, germinoma, and lymphoma are excluded * Ability to provide written informed consent Exclusion Criteria: * Contra-indication for MRI * Prior treatment for BM (i.e. surgery, SRS or WBRT) * Concurrent use of systemic therapy * Maximum cumulative GTV of more than 30cm3 on planning-MRI * More than 10 BM on planning-MRI * A brainstem metastasis with a PTV of more than 20 cm3
References
Publications (6)
- RESULTGijtenbeek JM, Ho VK, Heesters MA, Lagerwaard FJ, de Graeff A, Boogerd W. [Practice guideline 'Brain metastases' (revision)]. Ned Tijdschr Geneeskd. 2011;155(52):A4141. Dutch. PMID 22217243
- RESULTYamamoto M, Serizawa T, Shuto T, Akabane A, Higuchi Y, Kawagishi J, Yamanaka K, Sato Y, Jokura H, Yomo S, Nagano O, Kenai H, Moriki A, Suzuki S, Kida Y, Iwai Y, Hayashi M, Onishi H, Gondo M, Sato M, Akimitsu T, Kubo K, Kikuchi Y, Shibasaki T, Goto T, Takanashi M, Mori Y, Takakura K, Saeki N, Kunieda E, Aoyama H, Momoshima S, Tsuchiya K. Stereotactic radiosurgery for patients with multiple brain metastases (JLGK0901): a multi-institutional prospective observational study. Lancet Oncol. 2014 Apr;15(4):387-95. doi: 10.1016/S1470-2045(14)70061-0. Epub 2014 Mar 10. PMID 24621620
- RESULTZindler JD, Rodrigues G, Haasbeek CJ, De Haan PF, Meijer OW, Slotman BJ, Lagerwaard FJ. The clinical utility of prognostic scoring systems in patients with brain metastases treated with radiosurgery. Radiother Oncol. 2013 Mar;106(3):370-4. doi: 10.1016/j.radonc.2013.01.015. Epub 2013 Mar 20. PMID 23522151
- RESULTLangley RE, Stephens RJ, Nankivell M, Pugh C, Moore B, Navani N, Wilson P, Faivre-Finn C, Barton R, Parmar MK, Mulvenna PM; QUARTZ Investigators. Interim data from the Medical Research Council QUARTZ Trial: does whole brain radiotherapy affect the survival and quality of life of patients with brain metastases from non-small cell lung cancer? Clin Oncol (R Coll Radiol). 2013 Mar;25(3):e23-30. doi: 10.1016/j.clon.2012.11.002. Epub 2012 Dec 2. PMID 23211715
- DERIVEDHartgerink D, Bruynzeel A, Eekers D, Swinnen A, Hurkmans C, Wiggenraad R, Swaak-Kragten A, Dieleman E, van der Toorn PP, van Veelen L, Verhoeff JJC, Lagerwaard F, de Ruysscher D, Lambin P, Zindler J. Quality of life among patients with 4 to 10 brain metastases after treatment with whole-brain radiotherapy vs. stereotactic radiotherapy: a phase III, randomized, Dutch multicenter trial. Ann Palliat Med. 2022 Apr;11(4):1197-1209. doi: 10.21037/apm-21-1545. Epub 2021 Nov 18. PMID 34806396