Brain metastasis (BM) is among the most feared complications in cancer because even small tumors may cause incapacitating neurologic symptoms. It is observed in more than 50% of patients with lung cancer and 15% to 25% of patients with breast cancer. Temozolomide (TMZ) is an oral alkylating agent that crosses blood-brain barrier (BBB). This pilot study aims to evaluate the efficacy, safety and tolerability of whole-brain radiotherapy (WBRT) plus concomitant TMZ in lung cancer and breast cancer patients with BM.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
WBRT: 30 Gy in 15 fractions (2 Gy per fraction, 5 fractions per week) CT: TMZ 200 mg p.o. q.d. x 5 days per week x 3 weeks
Far Eastern Memorial Hospital
New Taipei City, Taiwan
objective response rate (ORR)
To evaluate the objective response rate (ORR) of WBRT plus concomitant TMZ treatment in lung cancer and breast cancer patients with BM.
Time frame: assessments will be conducted between 10 to 14 weeks after the end of treatment, all subjects will be followed every 3 months since Month 6 until completion of study (12 months after the last patient is enrolled) or death, whichever comes first.
Progression free survival (PFS)
Progression free survival (PFS), Overall survival (OS), Change from baseline in MMSE scores, Change from baseline in SF-36
Time frame: assessments will be conducted between 10 to 14 weeks after the end of treatment, all subjects will be followed every 3 months since Month 6 until completion of study (12 months after the last patient is enrolled) or death, whichever comes first.
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