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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029997
Receipt No. R000033928
Scientific Title Confirmatory Trial of Non-amputative Digit Preservation Surgery in Subungual Melanoma (JCOG1602, J-NAIL)
Date of disclosure of the study information 2017/11/16
Last modified on 2017/11/16

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Basic information
Public title Confirmatory Trial of Non-amputative Digit Preservation Surgery in Subungual Melanoma (JCOG1602, J-NAIL)
Acronym Confirmatory Trial of Non-amputative Digit Preservation Surgery in Subungual Melanoma (JCOG1602, J-NAIL)
Scientific Title Confirmatory Trial of Non-amputative Digit Preservation Surgery in Subungual Melanoma (JCOG1602, J-NAIL)
Scientific Title:Acronym Confirmatory Trial of Non-amputative Digit Preservation Surgery in Subungual Melanoma (JCOG1602, J-NAIL)
Region
Japan

Condition
Condition Subungual melanoma (Nail apparatus melanoma)
Classification by specialty
Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of non-amputative digit preservation surgery in patients with subungual melanoma without distant metastasis or invasion to bone.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Major Relapse-Free Survival : Major RFS
Key secondary outcomes Local relapse-free survival, Digit-preservation survival, Relapse-free survival, Overall survival, Partial relapse-free survival, Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 A: Non-amputative digit preservation surgery with/without sentinel lymph node biopsy or lymph node dessection
Interventions/Control_2
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)Suspected subungual melanoma by clinical findings and dermoscopy image, or diagnosed subungual melanoma by biopsy specimen
2)Not diagnosed as carcinoma in situ by clinical findings and dermoscopy image
3)Circumference of tumor including Hutchinson spread 80% or less of perimeter of phalanx
4)No satellite metastases or in-transit metastases
5)No tumor invasion to distal phalanx cortical bone by X-ray examination
6)No distant metastases in whole-body computed tomography
7)No unresectable lymph node metastases
8)Age >= 20 and =< 80
9)An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2
10)No previous surgery or chemotherapy or interferon therapy or radiotherapy or immunotherapy for subungual melanoma
11)Adequate organ and marrow function as defined below within 28 days prior to registration:
a) White blood cell >= 2,500 /mm3
b) Hemoglobin >= 9.0 g/dL
c) Platelets >= 8X104 /mm3
d) Total bilirubin =< 2.0 mg/dL
e) AST=< 150 IU/L
f) ALT=< 150 IU/L
12)Written informed consent
Key exclusion criteria 1)Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or intramucosal tumors curatively treated with local therapy
2)Active infection requiring systemic therapy
3)Body temperature >= 38 degrees Celsius
4)Women during pregnancy, within 28 days of postparturition, or during lactation. Men with favoring gestation of their partners.
5)Severe psychiatric disease
6)Patients requiring systemic steroid medication or the other immunosuppressive drug
7)Poorly controlled diabetes.
8)Poorly controlled hypertension.
9)History of unstable angina pectoris within 3 weeks or myocardial infarction within 6 months before registration.
Target sample size 85

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoya Yamazaki, MD, PhD
Organization National cancer center hospital
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 Yasuhiro Nakamura, MD, PhD
Organization JCOG1602 Coordinating Office
Division name Saitama medical university International medical Center
Zip code
Address Yamane1397-1, Hidaka city, Saitama 3501298, Japan
TEL 042-984-4111
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)
大阪国際がんセンター(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
2017 Year 11 Month 16 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 16 Day
Last follow-up date
2029 Year 05 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 16 Day
Last modified on
2017 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033928

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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