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.
Dutch guideline advices stereotactic radiosurgery (SRS) for patients with 1 up to 3 brain metastases (BM) and whole brain radiotherapy (WBRT) for patients with 4 or more BM. The interim analysis from the QUARTZ study showed that WBRT did not provide benefit in quality of life nor survival over best supportive care. WBRT has significant side effects, such as hair loss, fatigue, and cognitive dysfunction which may impair quality of life. A recently published study showed that SRS in patients with 5 up to 10 BM had a comparable survival to patients treated with 2 up to 4 BM. Many systemic therapies do not have a satisfactory intracranial response, because of the blood-brain barrier. The potential advantages of SRS i.e, limiting radiation doses to the uninvolved brain and a high rate of local tumour control by just a single treatment. Next logic step would be to compare WBRT with SRS alone in patients with 4-10 BM and evaluate whether SRS is superior to WBRT with regard to QOL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Stereotactic Radiosurgery for patients with 4 up to 10 brain metastases
Whole Brain Radiotherapy for patients with 4 up to 10 brain metastases
VUmc
Amsterdam, Netherlands
AMC
Amsterdam, Netherlands
ZRTI
Flushing, Netherlands
Maastricht Radiation Oncology (MAASTRO clinic)
Maastricht, Netherlands
Quality of life in patients with 4 - 10 brain metastases comparing WBRT and SRS
Quality of life is measured by the EQ-5D-5L, a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression)
Time frame: Change in quality of life measured from baseline to 3 months after radiotherapy
Overall survival steroid use (mg), toxicity including hair loss and fatigue.
Overall survival
Time frame: 1 year
Time that patient is functioning independently (Karnofsky ≥ 70)
Time that patient is functioning independently (Karnofsky ≥ 70)
Time frame: Change in Karnofsky index from baseline to 3 months after radiotherapy
Steroid use
Steroid use in mg over time
Time frame: Change in steroid use from baseline to 3 months after radiotherapy
Toxicity measured by hair loss and fatigue
Toxicity measured by hair loss and fatigue using CTCAE version 4.0
Time frame: Change in toxicity from baseline to 3 months after radiotherapy
Degree of independence
Degree of independence of patients using the Barthel index
Time frame: Change in independence from baseline to 3 months after radiotherapy
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Erasmus MC
Rotterdam, Netherlands
Haaglanden MC
The Hague, Netherlands
Instituut Verbeeten
Tilburg, Netherlands