Accelerated fractionation versus conventional fractionation radiation therapy for glottic cancer of T1-2N0M0 Phase III study: Japan Clinical Oncology Group study (JCOG 0701).
A randomized Phase III study was started in Japan to demonstrate the non-inferiority of survival of accelerated fractionation radiation therapy (2.4 Gy/fr) with conventional fractionation radiation therapy (2 Gy/fr) in patients with T1-2N0M0 glottic cancer. This study began in September 2007, and a total of 360 patients will be accrued from 22 institutions within 4 years. The primary endpoint is 3-year progression-free survival (PFS). The secondary endpoints are overall survival, local progression-free survival, disease-free survival, survival with preserved voice function, complete response rate, proportion of treatment completion and adverse events.
Nakamura
Kenichi
K
Clinical Trials and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan.
Kodaira
Takeshi
T
Shikama
Naoto
N
Kagami
Yoshikazu
Y
Ishikura
Satoshi
S
Shibata
Taro
T
Hiraoka
Masahiro
M
D000328:Adult; D000368:Aged; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D005260:Female; D005931:Glottis; D006801:Humans; D007564:Japan; D007822:Laryngeal Neoplasms / Q000473:pathology* / Q000503:physiopathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011878:Radiotherapy / Q000009:adverse effects / Q000379:methods; D011879:Radiotherapy Dosage; D016019:Survival Analysis; D016896:Treatment Outcome; D014832:Voice Disorders / Q000517:prevention & control