UMIN-CTR Clinical Trial

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

Cutaneous melanoma

Classification by specialty

Dermatology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Overall survival

Key secondary outcomes

Recurrence-free survival, Distant metastasis-free survival, pattern of recurrence, adverse events

Study type

Interventional

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

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

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

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

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2015

Year

05

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

05

Month

11

Day

Last modified on

2021

Year

01

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020028