Journal
JAPANESE JOURNAL OF CLINICAL ONCOLOGY
Volume 47, Issue 7, Pages 664-667Publisher
OXFORD UNIV PRESS
DOI: 10.1093/jjco/hyx063
Keywords
melanoma; adjuvant therapy; interferon beta; randomized controlled trial
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Funding
- Practical Research for Innovative Cancer Control from Japan Agency for Medical Research and Development (AMED) [17ck0106352h0001]
- National Cancer Center Research and Development Fund [26-A-4, 29-A-3]
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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. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000017494 [http://www.umin.ac.jp/ctr/index.htm].
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