A randomized phase III trial of adjuvant therapy with locoregional IFN-beta versus observation in stage II/III cutaneous melanoma (JCOG1309, J-FERON Trial)
- Conditions
- Cutaneous melanoma
- Registration Number
- JPRN-UMIN000017494
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 240
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Recurrence-free survival, Distant metastasis-free survival, pattern of recurrence, adverse events