Unique ID issued by UMIN | UMIN000043511 |
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Receipt number | R000049504 |
Scientific Title | Confirmatory trial of narrower side margins for basal cell carcinoma in Japanese population (JCOG2005, J-BASE-MARGIN) |
Date of disclosure of the study information | 2021/03/03 |
Last modified on | 2021/03/03 11:32:25 |
Confirmatory trial of narrower side margins for basal cell carcinoma in Japanese
population (JCOG2005,J-BASE-MARGIN)
Confirmatory trial of narrower side margins for basal cell carcinoma in Japanese
population (JCOG2005, J-BASE-MARGIN)
Confirmatory trial of narrower side margins for basal cell carcinoma in Japanese
population (JCOG2005, J-BASE-MARGIN)
Confirmatory trial of narrower side margins for basal cell carcinoma in Japanese
population (JCOG2005, J-BASE-MARGIN)
Japan |
Head and neck basal cell carcinoma
Dermatology |
Malignancy
NO
To evaluate the efficacy and safety of excision with a narrower margin in patients with Japanese (Asian) primary basal cell carcinoma of the head and neck.
Safety,Efficacy
Confirmatory
Phase III
5-year local recurrence rate
Margin positivity rate (positive side-margin rate, positive deep-margin rate and both), adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
A:2-mm side margin for well-defined clinical border (+ reconstruction)
B: 3-mm side margin for poorly defined clinical border (+ reconstruction)
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1) Solitary head and neck basal cell carcinoma without treatment.
2) Diagnosed as basal cell carcinoma by incisional biopsy or dermoscopy image.
3) Basal cell carcinoma with a largest diameter between 3 mm to 20 mm.
4) No palpable, swollen regional lymph nodes (cN0, AJCC-TNM 8th edition).
5) Three or four grandparents of the patients are so-called yellow race.
6) Age >= 20 and =< 85 (male) and age >= 20 and =< 90 (female).
7) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
8) No history of previous treatments including cryotherapy, electrocoagulation, curettage, or radiotherapy or imiquimod for basal cell carcinoma.
9) Adequate organ and marrow function as defined below within 28 days prior to registration:
a) White blood cell >= 2,000 /mm3
b) Hemoglobin >= 7.5 g/dL
c) Platelets >= 90,000 /mm3
d) Total bilirubin =< 4.0 mg/dL
e) AST=< 100 IU/L
f) ALT=< 100 IU/L
g) Creatinine =< 1.8 mg/dL
10)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) Poorly controlled diabetes.
7) Poorly controlled hypertension.
8) History of unstable angina pectoris within 3 weeks or myocardial infarction within 6 months before registration.
410
1st name | Yasuhiro |
Middle name | |
Last name | Nakamura |
Saitama Medical University International Medical Center
Skin Oncology/Dermatology
350-1298
1397-1 Yamane, Hidaka, Saitama, Japan
042-984-4111
JCOG_sir@ml.jcog.jp
1st name | Yasuhiro |
Middle name | |
Last name | Nakamura |
JCOG2005 Coordinating Office
Department of Skin Oncology/Dermatology, Saitama Medical University International Medical Center
350-1298
1397-1 Yamane, Hidaka, Saitama, Japan
042-984-4111
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Japan Clinical Oncology Group (JCOG)
National Cancer Center
Other
Japan
National Cancer Center Institutional Review Board
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
NO
北海道大学病院(北海道)
旭川医科大学(北海道)
札幌医科大学(北海道)
筑波大学医学医療系(茨城県)
埼玉県立がんセンター(埼玉県)
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)
がん・感染症センター都立駒込病院(東京都)
慶應義塾大学病院(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)
京都大学医学部附属病院(京都府)
大阪国際がんセンター(大阪府)
国立病院機構九州がんセンター(福岡県)
福岡大学医学部(福岡県)
九州大学病院(福岡県)
熊本大学病院(熊本県)
国立病院機構鹿児島医療センター(鹿児島県)
2021 | Year | 03 | Month | 03 | Day |
Unpublished
Open public recruiting
2020 | Year | 12 | Month | 25 | Day |
2021 | Year | 02 | Month | 24 | Day |
2021 | Year | 03 | Month | 03 | Day |
2037 | Year | 03 | Month | 03 | Day |
Age-upper limit
male:85 years old <=
female:90 years old >=
2021 | Year | 03 | Month | 03 | Day |
2021 | Year | 03 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049504
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