Daily irradiation versus irradiation at two- to three-day intervals in stereotactic radiotherapy for patients with 1-5 brain metastases: a multicenter randomized phase II trial
One to five brain metastases with less than 3.0 cm diameter.
In stereotactic radiotherapy (SRT) of 27-30 Gy in three fractions for patients with one to five brain metastases with less than 3.0 cm diameter, daily irradiation is used in the standard arm while irradiation at two- to three-day intervals is performed in the experimental arm. Both arms are performed daily with a total dose of 27-30 Gy in 3 fractions (9-10 Gy per fraction). Arm 1 (standard arm): consecutive daily irradiation; total SRT duration, 3 days. Arm 2 (experimental arm): irradiation at two- to three-day intervals; total SRT duration, 8 days. The study will employ a 1:1 randomization between Arm 1 (consecutive daily irradiation) and Arm 2 (irradiation at two- to three-day intervals). Patients will be stratified by (1) maximum diameter (≤ 2 cm vs. > 2 cm) among their brain metastases and (2) number of brain metastases (1, 2 vs. 3-5). Random assignment of treatment groups is centrally managed using the web-based system of Mujinwari (Iruka System Ltd., Tokyo, Japan).
1. Age 20 years or older. 2. Karnofsky Performance Status (KPS) > or = 70. 3. Total number of 1-5 brain metastases by enhanced magnetic resonance imaging (MRI). 4. Brain metastases with less than 3.0 cm diameter by enhanced magnetic resonance imaging (MRI). 5. Willing to provide informed consent.
1. Histological type of the primary site is lymphoma, small cell lung cancer, and germ cell tumor. 2. Metastases of the brainstem. 3. Meningeal carcinomatosis. 4. History of whole brain radiation therapy (WBRT) or substantial overlap with a previously treated radiation volume. 5. Surgical history for BM. 6. Difficult to be enrolled to the study by reason of insanity. 7. Inability to use enhancing agent for MRI due to low renal function or allergy. 8. In pregnancy or with expectation of pregnancy 9. Physician dismiss as subject of the study.