Format

Send to

Choose Destination
BMC Cancer. 2019 Oct 25;19(1):1002. doi: 10.1186/s12885-019-6248-2.

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

Author information

1
JCOG Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
2
Department of Skin Oncology/Dermatology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan. ynakamurta3@yahoo.co.jp.
3
Department of Dermatologic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
4
Department of Cutaneous Oncology, Cancer Institute Hospital, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
5
Department of Dermato-Oncology/Dermatology, National Hospital Organization Kagoshima Medical Center, 8-1 Kagoshima Shiroyama-cho, Kagoshima, 892-0853, Japan.
6
Department of Dermatologic Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Osaka Chuo-ku, Osaka, 541-8567, Japan.
7
Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University, 2-39-1 Kurokami, Kumamoto Chuo-ku, Kumamoto, 860-8555, Japan.

Abstract

BACKGROUND:

Amputation is the standard of care even for early-stage subungual melanomas (SUMs), known as nail apparatus melanoma, because the nail bed and nail matrix are close to the distal phalanx. However, a recent study demonstrated that not all patients with SUMs had histologic invasion of the underlying distal phalanx. As most SUMs occur in the thumb or big toe, amputation of either the thumb or big toe substantially interferes with activities of daily living, including poor cosmesis, loss of function, and phantom pain. Non-amputative digit preservation surgery can thus be applied in such cases without compromising patient prognosis.

METHODS:

We are conducting a multi-institutional single-arm trial to confirm the safety and efficacy of non-amputative digit preservation surgery. We will compare our results with those reported in the Japanese Melanoma Study, in which patients underwent amputation for SUMs as a traditional standard of care. Patients aged between 20 and 80 years with stage I, II, or III without evidence of tumor invasion to the underlying distal phalanx on preoperative radiograph are included in the study. The primary endpoint is major relapse-free survival (major RFS), which does not include local recurrence as an event; secondary endpoints include overall survival, digit-preservation survival, relapse-free survival, local relapse-free survival, partial relapse-free survival, and incidence of adverse events. A total of 85 patients from 21 Japanese institutions will be recruited within 5.5 years, and the follow-up period will last at least 5 years. The Japan Clinical Oncology Group Protocol Review Committee approved this study protocol in August 2017, and patient enrollment began in November 2017. Ethical approval was obtained from each institution's Institutional Review Board prior to patient enrollment.

DISCUSSION:

This is the first prospective trial to confirm the safety and efficacy of non-amputative digit preservation surgery for SUM without distant metastasis or bony invasion. The results of this trial could provide evidence to support this less-invasive surgery as a new standard of care to preserve adequately functioning digits.

TRIAL REGISTRATION:

Registry number: UMIN000029997 . Date of Registration: 16/Nov/2017. Date of First Participant Enrollment: 12/Dec/2017.

KEYWORDS:

Amputation; Non-amputative digit preservation surgery; Nonrandomized trial; Single arm confirmatory trial; Subungual melanoma

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center