UMIN-CTR Clinical Trial

Basic information
Public title	A randomized phase III trial of adjuvant therapy with locoregional IFN-beta versus observation in stage II/III cutaneous melanoma (JCOG1309, J-FERON Trial)
Acronym	A randomized phase III trial of adjuvant therapy with locoregional IFN-beta versus observation in stage II/III cutaneous melanoma (JCOG1309, J-FERON Trial)
Scientific Title	A randomized phase III trial of adjuvant therapy with locoregional IFN-beta versus observation in stage II/III cutaneous melanoma (JCOG1309, J-FERON Trial)
Scientific Title:Acronym	A randomized phase III trial of adjuvant therapy with locoregional IFN-beta versus observation in stage II/III cutaneous melanoma (JCOG1309, J-FERON Trial)
Region	Japan

Condition
Condition	Cutaneous melanoma
Classification by specialty	Dermatology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the superiority of adjuvant therapy with locoreginal interferon-beta in terms of overall survival to observation in patients with pathological stage II/III cutaneous metanoma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Recurrence-free survival, Distant metastasis-free survival, pattern of recurrence, adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A: Patients receive intra or sub-cutaneous injection of interferon beta at a flat dose of 3MU around primary site once a day. Treatment repeats for 10 consecutive days every 8 weeks for a total of 3 courses in an induction phase, and then repeats once every 4 weeks for 2 and a half years in a maintenance phase.
Interventions/Control_2	B: Observasion
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients must be histologically confirmed as having primary cutaneous melanoma. 2) Patients must belong to pathological stage of II or III in the 7th AJCC-TNM classification. 3) Patients must have undergone curative surgery within 9 weeks prior to enrollment. 4) Primary melanoma must be completely resected with clear margins. 5) Patients who underwent sentinel lymph node (SLN) biopsy must fulfill one of the following conditions: a) SLNs were examined using immunohistochemistry (HMB-45 and/or MART-1/Melan A) in addition to routine H&E stain, and histologically confirmed as negative for metastasis. b) Patients with positive SLNs must have undergone an adequate complete lymph node dissection (CLND). The number of harvested lymph nodes must be equal or more than 15 in neck, 10 in axilla, and 5 in groin. 6) Patients with clinically positive lymph nodes must have undergone an adequate CLND. The number of harvested lymph nodes must be equal or more than 15 in neck, 10 in axilla, and 5 in groin. 7) No history of previous treatment for malignancy. 8) No history of treatment using any kind of interferon. 9) Patients are aged from 20 to 80 years old at the time of enrollment. 10) Patients with the ECOG performance status 0 or 1. 11) Patients must have adequate organ and marrow function as defined below within 28 days prior to enrollment: a) Absolute neutrophil count >= 1,200 /mm3 b) Hemoglobin >= 8.0 g/dL c) Platelets >= 10X104 /mm3 d) Total bilirubin =< 2.0 mg/dL e) AST=< 100 IU/L f) ALT=< 100 IU/L g) Creatinine =< 1.5 mg/dL 12) Patients who provide a personally signed and dated informed consent document.
Key exclusion criteria	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.
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoya Yamazaki
Organization	National Cancer Center Hospital, Japan
Division name	Department of Dermatologic Oncology
Zip code
Address	Tsukiji 5-1-1, Chuo-ku, Tokyo 1040045, Japan
TEL	03-3542-2511
Email	nyamazak@ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Kenjiro Namikawa
Organization	JCOG1309 Coordinating Office
Division name	Department of Dermatologic Oncology, National Cancer Center Hospital
Zip code
Address	Tsukiji 5-1-1, Chuo-ku, Tokyo 1040045, Japan
TEL	03-3542-2511
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	National Cancer Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	北海道大学病院（北海道） 旭川医科大学（北海道） 筑波大学医学医療系（茨城県） 埼玉医科大学国際医療センター（埼玉県） 埼玉医科大学病院（埼玉県） 国立がん研究センター中央病院（東京都） 東京大学医学部（東京都） 新潟県立がんセンター新潟病院（新潟県） 富山県立中央病院（富山県） 信州大学医学部（長野県） 静岡県立静岡がんセンター（静岡県） 名古屋大学医学部（愛知県） 国立病院機構大阪医療センター（大阪府） 福岡大学医学部（福岡県） 九州大学病院（福岡県） 熊本大学医学部（熊本県） 国立病院機構鹿児島医療センター（鹿児島県）

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 03 Month 20 Day
Date of IRB	2015 Year 04 Month 23 Day
Anticipated trial start date	2015 Year 05 Month 11 Day
Last follow-up date	2027 Year 11 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 05 Month 11 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020028