Unique ID issued by UMIN | UMIN000029997 |
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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 |
Confirmatory Trial of Non-amputative Digit Preservation Surgery in Subungual Melanoma (JCOG1602, J-NAIL)
Confirmatory Trial of Non-amputative Digit Preservation Surgery in Subungual Melanoma (JCOG1602, J-NAIL)
Confirmatory Trial of Non-amputative Digit Preservation Surgery in Subungual Melanoma (JCOG1602, J-NAIL)
Confirmatory Trial of Non-amputative Digit Preservation Surgery in Subungual Melanoma (JCOG1602, J-NAIL)
Japan |
Subungual melanoma (Nail apparatus melanoma)
Dermatology |
Malignancy
NO
To evaluate the efficacy and safety of non-amputative digit preservation surgery in patients with subungual melanoma without distant metastasis or invasion to bone.
Safety,Efficacy
Confirmatory
Phase III
Major Relapse-Free Survival : Major RFS
Local relapse-free survival, Digit-preservation survival, Relapse-free survival, Overall survival, Partial relapse-free survival, Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
A: Non-amputative digit preservation surgery with/without sentinel lymph node biopsy or lymph node dessection
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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
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.
85
1st name | |
Middle name | |
Last name | Naoya Yamazaki, MD, PhD |
National cancer center hospital
Department of Dermatologic Oncology
Tsukiji 5-1-1, Chuo-ku, Tokyo 1040045, Japan
03-3542-2511
nyamazak@ncc.go.jp
1st name | |
Middle name | |
Last name | Yasuhiro Nakamura, MD, PhD |
JCOG1602 Coordinating Office
Saitama medical university International medical Center
Yamane1397-1, Hidaka city, Saitama 3501298, Japan
042-984-4111
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Japan Clinical Oncology Group (JCOG)
National Cancer Center
Other
Japan
NO
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)
2017 | Year | 11 | Month | 16 | Day |
Unpublished
Open public recruiting
2017 | Year | 08 | Month | 23 | Day |
2017 | Year | 11 | Month | 16 | Day |
2029 | Year | 05 | Month | 16 | Day |
2017 | Year | 11 | Month | 16 | Day |
2017 | Year | 11 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033928
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