This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for refractory brain metastases.
This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Tomotherapy: The regular fraction modes were as follows: a. lesions≥3 cm:52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions\<2cm:36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm: 40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem:50-60Gy/2.5-3Gy/20f; 3. multiple lesions with large lesion: whole brain radiation (WBRT) with 40Gy/2Gy/20f and concurrent boost of 60Gy/3Gy/20f 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
RECRUITINGObjective response rate
Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD
Time frame: 2-3 months after radiation
Overall survival rate
Time frame: up to 3 years
progress free survival rate
Time frame: up to 1 year
local control rate
Time frame: up to 1 year
intracranial progress free survival rate
Time frame: up to 1 year
adverse event
Time frame: from the day of radiation, up to 6 months
cause of death
Time frame: from the day of radiation to death date, up to 5 years
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