NIPH Clinical Trials Search

UMIN ID: UMIN000000819

Registered date:05/09/2007

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

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedT1-2N0M0 glottic cancer
Date of first enrollment2007/09/01
Target sample size360
Countries of recruitmentJapan
Study typeInterventional
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)


Primary Outcome3-year progression-free survival
Secondary Outcomeoverall 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 minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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


public contact
Name Naoto Shikama
Address 197, Usuda, Saku-City, Nagano, 384-0301, Japan Japan
Telephone 0267-82-3131
Affiliation JCOG0701 Coordinating Office Saku Central Hospital
scientific contact
Name Yoshikazu Kagami
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN Japan
Telephone 03-3542-2511
Affiliation National Cancer Center Hospital Radiation Oncology Division