학술논문
Daily irradiation versus irradiation at two- to three-day intervals in stereotactic radiotherapy for patients with 1-5 brain metastases: study protocol for a multicenter open-label randomized phase II trial
Document Type
Report
Author
Tomita, Natsuo; Ishiyama, Hiromichi; Makita, Chiyoko; Ohshima, Yukihiko; Nagai, Aiko; Baba, Fumiya; Kuno, Mayu; Otsuka, Shinya; Kondo, Takuhito; Sugie, Chikao; Kawai, Tatsuya; Takaoka, Taiki; Okazaki, Dai; Torii, Akira; Niwa, Masanari; Kita, Nozomi; Takano, Seiya; Kawakami, Shogo; Matsuo, Masayuki; Kumano, Tomoyasu; Ito, Makoto; Adachi, Sou; Abe, Souichiro; Murao, Takayuki; Hiwatashi, Akio
Source
BMC Cancer. December 5, 2022, Vol. 22 Issue 1
Subject
Language
English
ISSN
1471-2407
Abstract
Background Radiobiological daily changes within tumors are considered to be quite different between stereotactic radiotherapy (SRT) (e.g., 50 Gy in 4 fractions) and conventional radiotherapy (e.g., 60 Gy in 30 fractions). We aim to assess the optimal interval of irradiation in SRT and compare outcomes of daily irradiation with irradiation at two- to three-day intervals in SRT for patients with one to five brain metastases (BM). Methods This study is conducted as a multicenter open-label randomized phase II trial. Patients aged 20 or older with one to five BM, less than 3.0 cm diameter, and Karnofsky Performance Status [greater than or equal to]70 are eligible. A total of 70 eligible patients will be enrolled. After stratifying by the number of BMs (1, 2 vs. 3-5) and diameter of the largest tumor (< 2 cm vs. [greater than or equal to] 2 cm), we randomly assigned patients (1:1) to receive daily irradiation (Arm 1), or irradiation at two- to three-day intervals (Arm 2). Both arms are performed with total dose of 27-30 Gy in 3 fractions. The primary endpoint is an intracranial local control rate, defined as intracranial local control at initially treated sites. We use a randomized phase II screening design with a two-sided [alpha] of 0*20. The phase II trial is positive with p < 0.20. All analyses are intention to treat. This study is registered with the UMIN-clinical trials registry, number UMIN000048728. Discussion This study will provide an assessment of the impact of SRT interval on local control, survival, and toxicity for patients with 1-5 BM. The trial is ongoing and is recruiting now. Trial registration UMIN000048728. Date of registration: August 23, 2022. https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000055515. Keywords: Brain metastases, Radiation biology, Stereotactic radiation, Treatment outcome, Clinical Trial, Phase II
Author(s): Natsuo Tomita[sup.1] , Hiromichi Ishiyama[sup.2] , Chiyoko Makita[sup.3] , Yukihiko Ohshima[sup.4] , Aiko Nagai[sup.5] , Fumiya Baba[sup.6] , Mayu Kuno[sup.7] , Shinya Otsuka[sup.8] , Takuhito Kondo[sup.9] , Chikao Sugie[sup.10] [...]
Author(s): Natsuo Tomita[sup.1] , Hiromichi Ishiyama[sup.2] , Chiyoko Makita[sup.3] , Yukihiko Ohshima[sup.4] , Aiko Nagai[sup.5] , Fumiya Baba[sup.6] , Mayu Kuno[sup.7] , Shinya Otsuka[sup.8] , Takuhito Kondo[sup.9] , Chikao Sugie[sup.10] [...]