Head and neck basal cell carcinoma
Conditions
Interventions
A:2-mm side margin for well-defined clinical border (+ reconstruction) B: 3-mm side margin for poorly defined clinical border (+ reconstruction)
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Solitary head and neck basal cell carcinoma without treatment. 2) Diagnosed as basal cell carcinoma by incisional biopsy or dermoscopy image. 3) Basal cell carcinoma with a largest diameter between 3 mm to 20 mm. 4) No palpable, swollen regional lymph nodes (cN0, AJCC-TNM 8th edition). 5) Three or four grandparents of the patients are so-called yellow race. 6) Age >= 20 and =< 85 (male) and age >= 20 and =< 90 (female). 7) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3. 8) No history of previous treatments including cryotherapy, electrocoagulation, curettage, or radiotherapy or imiquimod for basal cell carcinoma. 9) Adequate organ and marrow function as defined below within 28 days prior to registration: a) White blood cell >= 2,000 /mm3 b) Hemoglobin >= 7.5 g/dL c) Platelets >= 90,000 /mm3 d) Total bilirubin =< 4.0 mg/dL e) AST=< 100 IU/L f) ALT=< 100 IU/L g) Creatinine =< 1.8 mg/dL 10)Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or intramucosal tumors curatively treated with local therapy. 2) Active infection requiring systemic therapy. 3) Body temperature >= 38 degrees Celsius. 4) Women during pregnancy, within 28 days of postparturition, or during lactation. Men with favoring gestation of their partners. 5) Severe psychiatric disease. 6) Poorly controlled diabetes. 7) Poorly controlled hypertension. 8) History of unstable angina pectoris within 3 weeks or myocardial infarction within 6 months before registration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year local recurrence rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Margin positivity rate (positive side-margin rate, positive deep-margin rate and both), adverse events | — |
Countries
Japan
Contacts
Public ContactYasuhiro Nakamura
JCOG2005 Coordinating Office Department of Skin Oncology/Dermatology, Saitama Medical University International Medical Center
Outcome results
None listed