Accelerated fractionation vs. conventional fractionation radiation therapy for glottic cancer of T1-2N0M0 Phase III study (JCOG0701)

UMIN ID: UMIN000000819

Registered date:05/09/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: T1-2N0M0 glottic cancer
• Date of first enrollment: 2007/09/01
• Target sample size: 360
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A: Conventional fractionation radiation therapy (2 Gy/fr; T1:66 Gy/33 fr, T2:70 Gy/35 fr)
B: Accelerated fractionation radiation therapy (2.4 Gy/fr; T1: 60 Gy/25 fr, T2: 64.8 Gy/27 fr)

Outcome(s)

• Primary Outcome: 3-year progression-free survival
• Secondary Outcome: overall survival, local progression-free survival, disease-free survival, survival with preserved voice function, complete response rate, proportion of treatment completion in specific term, adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Active bacterial or fungous infection. 2) Simultaneous or metachronous (within 5 years) double cancers. 3) Women during pregnancy or breast-feeding. 4) Psychosis. 5) Systemic steroids medication. 6) History of collagen disease except for rheumatism. 7) Uncontrollable diabetes mellitus or administration of insulin. 8) Hemodialysis medication 9) Uncontrollable hypertension. 10) History of severe heart disease, heart failure, myocardial infarction within 6 months or attack of angina pectoris within 6 months.

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare