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. 2012 Sep 12;2012(9):CD006121. doi: 10.1002/14651858.CD006121.pub3

Kondziolka 1999

Methods Single institution RCT
Power = 0.8: study was designed to detect a 40% increase in local control after WBRT plus SRS
Participants Inclusion criteria: patients with 2 to 4 MRI‐confirmed contrast‐enhancing brain metastases with a biopsy‐confirmed primary tumor. Tumor size ≤ 25 mm and > 5 mm from the optic chiasm. KPS ≥ 70
Exclusion criteria: KPS < 70
Interventions WBRT only: 14 patients received 30 Gy in 12 fractions
WBRT plus SRS: 13 patients received 30‐Gy WBRT plus 16‐Gy SRS to tumor margin
Outcomes Primary: local tumor control
Secondary: OS
Notes The study was stopped at 60% accrual at interim evaluation. The interim analysis revealed a "significant benefit in the rate of local tumour control" after WBRT plus SRS. Local control was assessed at 1.5, 3, 6, 9, 12, 15, and 18 months. The rate of local failure was 100% at 1 year in the WBRT alone group, "but only 8% in surviving patients who had SRS plus WBRT". No difference in OS was noted in both groups
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "The method of randomization consisted of a coin toss at the initial clinic visit"
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgment
Blinding (performance bias and detection bias) All outcomes Unclear risk "The data were collated and reviewed by an investigator independent from each treatment arm." It is unclear if the investigator assessing outcomes was blinded, it only notes that the investigator was independent
Incomplete outcome data (attrition bias) All outcomes Low risk % Analyzed in primary analyses: 27 out of /27 (100%)
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgment
Other bias Unclear risk Insufficient information to assess whether an important risk of bias exists

GK: Gamma Knife; KPS: Karnofsky Performance Status; MRI: magnetic resonance imaging; OS: overall survival; RCT: randomized controlled trial; RTOG: Radiation Therapy Oncology Group; SRS: stereotactic radiosurgery; WBRT: whole brain radiation therapy.