Inclusion criteria | |
1) Invasive subungual melanoma that is clearly diagnosable by clinical and dermoscopic findings alone or histologically diagnosable by a biopsy specimen. | |
2) Not suspected to be melanoma in situ by clinical findings or dermoscopy images. | |
3) Tumor circumference, including Hutchinson spread, ≤80% of the perimeter of the phalanx. | |
4) No satellite or in-transit metastases. | |
5) No tumor invasion to the distal phalanx cortical bone by X-ray examination. | |
6) No distant metastases on whole-body computed tomography. | |
7) No unresectable lymph node metastases. | |
8) Age ≤ 20 and ≤ 80 years. | |
9) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. | |
10) No previous treatment including surgery, chemotherapy, radiotherapy, or immunotherapy for primary cancer. | |
11) Adequate organ and marrow function as defined below within 28 days prior to registration: | |
a) White blood cell count ≥2500 /mm3 | |
b) Hemoglobin ≥9.0 g/dL | |
c) Platelet count ≤80,000 /mm3 | |
d) Total bilirubin ≤2.0 mg/dL | |
e) Aspartate aminotransferase ≤150 IU/L | |
f) Alanine aminotransferase ≤150 IU/L | |
Exclusion criteria | |
1) Synchronous or metachronous (within 5 years) malignancy, except cancer with a 5-year relative survival rate of 95% or more, such as carcinoma in situ, intramucosal tumor, or early-stage cancer. | |
2) Active infection requiring systemic therapy. | |
3) Body temperature ≥ 38 °C. | |
4) Women who are pregnant or nursing. | |
5) Patients with severe psychiatric disease. | |
6) Patients requiring systemic steroid medication or other immunosuppressive drugs. | |
7) Poorly controlled diabetes. | |
8) Poorly controlled hypertension. | |
9) History of unstable angina pectoris within 3 weeks or myocardial infarction within 6 months before registration. |