T1 bulky/T2 favorable Glottic carcinoma, squamous cell carcinoma
Conditions
Interventions
Treatment schedule: S-1 is taken orally once daily after breakfast and radiotherapy (RT) with 2.25 Gy/day, five days/week, to a total of 25 fractions (total dose of 56.25 Gy), is delivered. Oral S-1 a
Sponsors
Nagoya University Graduate School of Medicine, Department of Radiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) the primary site confirmed at glottis by laryngoscopy in 28 days before enrollment; (2) the T-stage diagnosed as bulky T1 or T2 without impaired cord mobility by laryngoscopy; (3) histologically- or cytologically- confirmed glottic squamous carcinoma; (4) Confirmed as N0M0 by chest X-ray or contrast-enhanced computer tomography; (5) no prior chemotherapy for malignancy within 5 years; (6) aged 20-80 years; (7) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; (8) no prior history of radiotherapy or surgery to the planned irradiation area; (9) willing to participate and sign informed consent; (10) adequate bone marrow, liver, and kidney functions.
Exclusion criteria
Exclusion criteria: (1) unable to take oral S-1; (2) with a history of severe allergy; (3) severe clinical infection; (4) with active double cancer including simultaneous cancer or metachronous cancer within 5 years, except for in situ or intramucosal carcinoma; (5) being pregnant or breast feeding; (6) with mental disease interfering participating the trial; (7) with severe bone marrow dysfunction; (8) with the history of kidney disease, such as getting dialysis; (9) with the history of severe liver disease; (10)with the history of severe lung disease, such as interstitial pneumonia of pulmonary fibrosis; (11) with the history of collagen disease; (12) with uncontrolled diabetes mellitus or insulin-dependent diabetes mellitus; (13) with uncontrolled hypertension; (14) cardiovascular diseases with clinical significance, such as heart failure, history of myocardial infarction or angina in the past half year; (15) taking drugs as follows; other pyrimidine compound- anticancer drug or flucytosine ; (16) jugged as inadequate case by doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year local control rate | — |
Countries
Japan
Contacts
Public ContactYoshiyuki Itoh
Nagoya University Graduate School of Medicine Department of Radiology
Outcome results
None listed