A randomized phase III study of short-course radiotherapy combined with Temozolomide in elderly patients with newly diagnosed glioblastoma; Japan clinical oncology group study JCOG1910 (AgedGlio-PIII)
Yoshiki Arakawa,
Keita Sasaki,
Yohei Mineharu,
Megumi Uto,
Takashi Mizowaki,
Junki Mizusawa,
Yuta Sekino,
Tomohiro Ono,
Hidefumi Aoyama,
Kaishi Satomi,
Koichi Ichimura,
Manabu Kinoshita,
Makoto Ohno,
Yoshinori Ito,
Ryo Nishikawa,
Haruhiko Fukuda,
Yasumasa Nishimura,
Yoshitaka Narita,
Brain Tumor Study Group and Radiation Therapy Study Group of the Japan Clinical Oncology Group
Affiliations
Yoshiki Arakawa
Department of Neurosurgery, Kyoto University Graduate School of Medicine
Keita Sasaki
JCOG Data Center/Operations Office, National Cancer Center Hospital
Yohei Mineharu
Department of Neurosurgery, Kyoto University Graduate School of Medicine
Megumi Uto
Department of Radiation Oncology and Image-Applied Therapy, Kyoto University Graduate School of Medicine
Takashi Mizowaki
Department of Radiation Oncology and Image-Applied Therapy, Kyoto University Graduate School of Medicine
Junki Mizusawa
JCOG Data Center/Operations Office, National Cancer Center Hospital
Yuta Sekino
JCOG Data Center/Operations Office, National Cancer Center Hospital
Tomohiro Ono
Department of Radiation Oncology and Image-Applied Therapy, Kyoto University Graduate School of Medicine
Hidefumi Aoyama
Department of Radiation Oncology, Faculty of Medicine, Hokkaido University
Kaishi Satomi
Department of Diagnostic Pathology, National Cancer Center Hospital
Koichi Ichimura
Department of Brain Disease Translational Research, Juntendo University Faculty of Medicine
Manabu Kinoshita
Department of Neurosurgery, Asahikawa Medical University
Makoto Ohno
Department of Neurosurgery and Neuro-Oncology, National Cancer Center Hospital
Yoshinori Ito
Department of Radiation Oncology, Showa University Graduate School of Medicine
Ryo Nishikawa
Department of Neuro-Oncology/Neurosurgery, Saitama Medical University International Medical Center
Haruhiko Fukuda
JCOG Data Center/Operations Office, National Cancer Center Hospital
Yasumasa Nishimura
Department of Radiation Oncology, Kindai University Faculty of Medicine
Yoshitaka Narita
Department of Neurosurgery and Neuro-Oncology, National Cancer Center Hospital
Brain Tumor Study Group and Radiation Therapy Study Group of the Japan Clinical Oncology Group
Abstract Background The current standard treatment for elderly patients with newly diagnosed glioblastoma is surgery followed by short-course radiotherapy with temozolomide. In recent studies, 40 Gy in 15 fractions vs. 60 Gy in 30 fractions, 34 Gy in 10 fractions vs. 60 Gy in 30 fractions, and 40 Gy in 15 fractions vs. 25 Gy in 5 fractions have been reported as non-inferior. The addition of temozolomide increased the survival benefit of radiotherapy with 40 Gy in 15 fractions. However, the optimal regimen for radiotherapy plus concomitant temozolomide remains unresolved. Methods This multi-institutional randomized phase III trial was commenced to confirm the non-inferiority of radiotherapy comprising 25 Gy in 5 fractions with concomitant (150 mg/m2/day, 5 days) and adjuvant temozolomide over 40 Gy in 15 fractions with concomitant (75 mg/m2/day, every day from first to last day of radiation) and adjuvant temozolomide in terms of overall survival (OS) in elderly patients with newly diagnosed glioblastoma. A total of 270 patients will be accrued from 51 Japanese institutions in 4 years and follow-up will last 2 years. Patients 71 years of age or older, or 71–75 years old with resection of less than 90% of the contrast-enhanced region, will be registered and randomly assigned to each group with 1:1 allocation. The primary endpoint is OS, and the secondary endpoints are progression-free survival, frequency of adverse events, proportion of Karnofsky performance status preservation, and proportion of health-related quality of life preservation. The Japan Clinical Oncology Group Protocol Review Committee approved this study protocol in April 2020. Ethics approval was granted by the National Cancer Center Hospital Certified Review Board. Patient enrollment began in August 2020. Discussion If the primary endpoint is met, short-course radiotherapy comprising 25 Gy in 5 fractions with concomitant and adjuvant temozolomide will be a standard of care for elderly patients with newly diagnosed glioblastoma. Trial registration Registry number: jRCTs031200099 . Date of Registration: 27/Aug/2020. Date of First Participant Enrollment: 4/Sep/2020.
