This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases.
This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases(≥3 lesions).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Whole brain radiation (WBRT) with 38-40Gy in 20 fractions and concurrent boost of 60-70Gy of the lesions. TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2\*5d, q28d, up to 6cycles.
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Disease control rate(DCR)
Using RTOG9508 criteria, tumor control is defined as CR+PR+SD
Time frame: 2-3 month after radiation
Overall survival
the time from radiation to death
Time frame: up to 3 years
progress free survival
the time from radiation to any progression
Time frame: up to 1 year
local control rate
the time from radiation to the treated brain metastases recurrence
Time frame: up to 1 year
intracranial progress free survival rate
the time from radiation to local recurrence and/or new brain metastases
Time frame: up to 1 year
adverse event
acute and late toxicities
Time frame: from the day of radiation, up to 3 years
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