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.

Inclusion Criteria:

• Histologically or cytologically confirmed lung cancer or breast cancer at primary site
• Patient with inoperable brain metastases
• Female or male, ≥ 20 and < 65 years of age
• Karnofsky performance status (KPS) ≥ 70%
• Life expectancy ≥ 12 weeks
• Adequate organ function
• Willing and able to provide a written informed consent

Exclusion Criteria:

• Female of childbearing potential* who is pregnant/lactating or planning to be pregnant
• Male whose partner is planning to be pregnant
• Inability to swallow
• Meningeal carcinomatosis
• History of hypersensitivity to iodinated contrast media, temozolomide or any component of the study drugs
• Prior use of temozolomide
• Use of systemic chemotherapy within 2 weeks prior to the initiation of study treatment
• Prior surgery, chemotherapy or radiotherapy for a brain neoplasm
• Current use of valproic acid
• Use of any investigational product within 4 weeks prior to the initiation of study treatment
• Patient with any condition or disease which is considered not suitable for this study by investigator