Skip to main content

Table 2 Inclusion and exclusion criteria for J-NAIL study

From: Confirmatory trial of non-amputative digit preservation surgery for subungual melanoma: Japan Clinical Oncology Group study (JCOG1602, J-NAIL study protocol)

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.