UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029997
Receipt number 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 10:33:03

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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 or person

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name



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

Value
https://center6.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