Whole brain radiotherapy versus stereotactic radiosurgery for 4–10 brain metastases: a phase III randomised multicentre trial

BMC Cancer

Study Protocol

Philippe Lambin¹  Daniëlle B. P. Eekers¹  Ans Swinnen¹  Jaap D. Zindler²  Coen W. Hurkmans³  Anna M. E. Bruynzeel⁴ 

[1] Department of Radiation Oncology (MAASTRO clinic), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, dr. Tanslaan 12, 6229ET, Maastricht, the Netherlands;Department of Radiation Oncology (MAASTRO clinic), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, dr. Tanslaan 12, 6229ET, Maastricht, the Netherlands;MAASTRO clinic, P.O. Box 3035, 6202, Maastricht, NA, The Netherlands;Department of Radiation Oncology, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands;Department of Radiation Oncology, VU University Medical Center, Boelelaan 1117, 1081 HV, Amsterdam, the Netherlands;

关键词: Brain metastases;    Stereotactic radiosurgery;    Whole brain radiotherapy;    Quality of life;   

DOI  :  10.1186/s12885-017-3494-z

 received in 2016-08-09, accepted in 2017-07-20,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundMaintenance of quality of life is the primary goal during treatment of brain metastases (BM). This is a protocol of an ongoing phase III randomised multicentre study. This study aims to determine the exact additional palliative value of stereotactic radiosurgery (SRS) over whole brain radiotherapy (WBRT) in patients with 4–10 BM.MethodsThe study will include patients with 4–10 BM from solid primary tumours diagnosed on a high-resolution contrast-enhanced MRI scan with a maximum lesional diameter of 2.5 cm in any direction and a maximum cumulative lesional volume of 30 cm3. Patients will be randomised between WBRT in five fractions of 4 Gy to a total dose of 20 Gy (standard arm) and single dose SRS to the BMs (study arm) in the range of 15–24 Gy. The largest BM or a localisation in the brainstem will determine the prescribed SRS dose. The primary endpoint is difference in quality of life (EQ5D EUROQOL score) at 3 months after radiotherapy with regard to baseline. Secondary endpoints are difference in quality of life (EQ5D EUROQOL questionnaire) at 6, 9 and 12 months after radiotherapy with regard to baseline. Other secondary endpoints are at 3, 6, 9 and 12 months after radiotherapy survival, Karnofsky ≥ 70, WHO performance status, steroid use (mg), toxicity according to CTCAE V4.0 including hair loss, fatigue, brain salvage during follow-up, type of salvage, time to salvage after randomisation and Barthel index. Facultative secondary endpoints are neurocognition with the Hopkins verbal learning test revised, quality of life EORTC QLQ-C30, quality of life EORTC BN20 brain module and fatigue scale EORTC QLQ-FA13.DiscussionWorldwide, most patients with more than 4 BM will be treated with WBRT. Considering the potential advantages of SRS over WBRT, i.e. limiting radiation doses to uninvolved brain and a high rate of local tumour control by just a single treatment with fewer side effects, such as hair loss and fatigue, compared to WBRT, SRS might be a suitable alternative for patients with 4–10 BM.Trial registrationTrial registration number: NCT02353000, trial registration date 15th January 2015, open for accrual 1st July 2016, nine patients were enrolled in this trial on 14th April 2017.

【 授权许可】

CC BY   
© The Author(s). 2017