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- Title
Randomized phase III trial of adjuvant therapy with locoregional interferon beta versus surgery alone in stage II/III cutaneous melanoma: Japan Clinical Oncology Group Study.
- Authors
Kenjiro Namikawa; Arata Tsutsumida; Tomonori Mizutani; Taro Shibata; Tatsuya Takenouchi; Shusuke Yoshikawa; Yoshio Kiyohara; Hiroshi Uchi; Masutaka Furue; Dai Ogata; Tetsuya Tsuchida; Naoya Yamazaki
- Abstract
The Dermatologic Oncology Group of Japan Clinical Oncology Group has started a randomized phase III trial to confirm the superiority of adjuvant therapy with locoregional interferon beta in overall survival over surgery alone for patients with pathological stage II/III cutaneous melanoma (JCOG1309). Patients in the interferon beta arm receive intra- or subcutaneous injections of interferon beta directly into the surgical site at a flat dose of 3 million units once per day. Treatment is repeated for 10 consecutive days every 8 weeks for a total of 3 courses during the induction phase, then 1-day injection every 4 weeks for 2.5 years. A total of 240 patients will be accrued from 17 Japanese institutions within 6.5 years. Primary endpoint is overall survival. Secondary endpoints are relapse-free survival, distant metastasis-free survival, pattern of recurrence, and adverse events.
- Publication
Japanese Journal of Clinical Oncology, 2017, Vol 47, Issue 7, p664
- ISSN
0368-2811
- Publication type
Article
- DOI
10.1093/jjco/hyx063