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Clinicalprotocolpdf
Clinicalprotocolpdf
Amanda Tabar
This was a randomized phase III clinical trial aimed at comparing the effectiveness of
stereotactic radiation therapy (SRS) alone versus SRS combined with whole-brain radiation
therapy (WBRT) in treating patients with 1 to 3 brain metastases from extracranial cancers
(e.g., lung, breast, prostate). The study assessed several outcomes: including overall survival,
time to central nervous system (CNS) failure, quality of life, duration of independence,
The primary purpose of this trial was to determine whether the addition of WBRT to
SRS improved overall survival in patients with brain metastases; while secondary objectives
included evaluating neurocognitive status, tumor control, quality of life, and post-treatment
toxicity. The study design was randomized and multicenter; with patients grouped based on
To quality for this study, participants had to have 1 to 3 brain metastases, each
measuring less than 3.0 cm, confirmed by contrast MRI within 21 days of start. They had to be
eligible for treatment with either gamma knife or linear accelerator-based radiosurgery.
Patients with primary germ cell tumors, small cell carcinoma, lymphoma, or leptomeningeal
metastases were excluded. Next, the trial randomly assigned participants to two treatment arms:
Arm I: Patients will undergo SRS alone. Arm II: Patients will receive SRS followed by WBRT
within 14 days.
The study assessed neurocognitive progression, local and distant tumor control at 3
months, overall quality of life from baseline to 3 months, long-term neurocognitive status at
12 months, and overall survival up to 5 years. The findings at the 3-month mark indicated that
patients who received WBRT + SRS experienced more cognitive decline compared to those
who received SRS alone (88.0% vs. 61.9%). Specifically, deterioration was observed in
immediate recall (31% vs. 8%), delayed recall (51% vs. 20%, p = 0.002), and verbal abilities
(19% vs. 2%). However, SRS + WBRT led to better intracranial tumor control at 6 and 12
months compared to SRS alone (66.1% and 50.5% vs. 88.3% and 84.9%). Nonetheless,
regardless of tumor control, overall survival did not extensively differ between the two
groups: with average survival being 10.7 months for SRS alone and 7.5 months for SRS +
WBRT.1
decline, particularly in immediate recall, memory, and verbal abilities. Despite improving brain
tumor control, the addition of WBRT to SRS did not result in improved overall survival. The
study authors recommended initial treatment with SRS as the best approach to preserve
cognitive function in patients with newly diagnosed brain metastases that are responsive to
SRS alone.
References
1. Brown PD, Asher AL, Ballman KV, et al. NCCTG N0574 (Alliance): A phase III
2015;33(18_suppl):LBA4-LBA4. doi:https://doi.org/10.1200/
jco.2015.33.18_suppl.lba4
clinicaltrials.gov. https://classic.clinicaltrials.gov/ct2/show/NCT00377156