A randomized phase III trial of adjuvant therapy with locoregional IFN-beta versus observation in stage II/III cutaneous melanoma (JCOG1309, J-FERON Trial) - A randomized phase III trial of adjuvant therapy with locoregional IFN-beta versus observation in stage II/III cutaneous melanoma (JCOG1309, J-FERON Trial)

Japan Clinical Oncology Group (JCOG)0 个研究点目标入组 240 人开始时间: 2015年5月11日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Patients with a concurrent malignancy (within 5 years) except for carcinoma in situ or basal cell carcinomas which were curatively treated with local therapy. 2) Patients with ongoing or active infection which requires systemic therapy. 3) Patients with a fever at equal or more than 38 degree Celsius. 4) Pregnant, possible pregnant, or lactating women. Within 28 days after childbirth. 5) Patients with a psychiatric illness or social situations that would limit compliance with study requirements. 6) Patients who are receiving systemic administration of steroid or other immunosuppressants. 7) Patients with an unstable angina pectoris or history of cardiac infarction within 6 months. 8) Patients with an uncontrolled diabetes mellitus, or continuously treated with insulin. 9) Patients with positive HIV antibody. 10) Patients with interstitial pneumonia, severe pulmonary fibrosis, or emphysema. 11) Patients have a history of an autoimmune hepatitis. 12) Patients who are taking Shosaikoto (a herbal drug). 13) Patients who have a history of allergy to materials of interferon beta, materials derived from cow, or biological drugs.

发起方

Japan Clinical Oncology Group (JCOG)