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JAPANESE
国立保健医療科学院
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)

Outcome(s)

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 criteria1) Primary tumor site is vocal cord. 2) Histologically proven squamous cell carcinoma. 3) Extent of primary tumor is evaluated as T1 or T2 without impaired cord morbidity. 4) Clinical N0/M0. 5) Planned radiation therapy fulfill limitation of overall treatment time. 6) Aged 20 to 80 years old. 7) Performance status of 0 or 1. 8) No prior surgery or radiation therapy against larynx. 9) No prior chemotherapy against any malignancies. 10) Sufficient organ functions. 11) Written informed consent.
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

Contact

public contact
Name Naoto Shikama
Address 197, Usuda, Saku-City, Nagano, 384-0301, Japan Japan
Telephone 0267-82-3131
E-mail JCOG_sir@ml.jcog.jp
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
E-mail
Affiliation National Cancer Center Hospital Radiation Oncology Division