T1-2N0M0 glottic cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
JCOG0701 Coordinating Office Saku Central Hospital