Subungual melanoma (Nail apparatus melanoma)
Conditions
Interventions
A: Non-amputative digit preservation surgery with/without sentinel lymph node biopsy or lymph node dessection
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Suspected subungual melanoma by clinical findings and dermoscopy image, or diagnosed subungual melanoma by biopsy specimen 2)Not diagnosed as carcinoma in situ by clinical findings and dermoscopy image 3)Circumference of tumor including Hutchinson spread 80% or less of perimeter of phalanx 4)No satellite metastases or in-transit metastases 5)No tumor invasion to distal phalanx cortical bone by X-ray examination 6)No distant metastases in whole-body computed tomography 7)No unresectable lymph node metastases 8)Age >= 20 and =< 80 9)An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2 10)No previous surgery or chemotherapy or interferon therapy or radiotherapy or immunotherapy for subungual melanoma 11)Adequate organ and marrow function as defined below within 28 days prior to registration: a) White blood cell >= 2,500 /mm3 b) Hemoglobin >= 9.0 g/dL c) Platelets >= 8X104 /mm3 d) Total bilirubin =< 2.0 mg/dL e) AST=< 150 IU/L f) ALT=< 150 IU/L 12)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)Patients requiring systemic steroid medication or the other immunosuppressive drug 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Relapse-Free Survival : Major RFS | — |
Secondary
| Measure | Time frame |
|---|---|
| Local relapse-free survival, Digit-preservation survival, Relapse-free survival, Overall survival, Partial relapse-free survival, Adverse events | — |
Countries
Japan
Contacts
Public ContactYasuhiro Nakamura, MD, PhD
JCOG1602 Coordinating Office Saitama medical university International medical Center
Outcome results
None listed