UMIN-CTR Clinical Trial

Basic information
Public title	Confirmatory trial of narrower side margins for basal cell carcinoma in Japanese population (JCOG2005,J-BASE-MARGIN)
Acronym	Confirmatory trial of narrower side margins for basal cell carcinoma in Japanese population (JCOG2005, J-BASE-MARGIN)
Scientific Title	Confirmatory trial of narrower side margins for basal cell carcinoma in Japanese population (JCOG2005, J-BASE-MARGIN)
Scientific Title:Acronym	Confirmatory trial of narrower side margins for basal cell carcinoma in Japanese population (JCOG2005, J-BASE-MARGIN)
Region	Japan

Condition
Condition	Head and neck basal cell carcinoma
Classification by specialty	Dermatology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	5-year local recurrence rate
Key secondary outcomes	Margin positivity rate (positive side-margin rate, positive deep-margin rate and both), 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:2-mm side margin for well-defined clinical border (+ reconstruction) B: 3-mm side margin for poorly defined clinical border (+ reconstruction)
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	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.
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) Poorly controlled diabetes. 7) Poorly controlled hypertension. 8) History of unstable angina pectoris within 3 weeks or myocardial infarction within 6 months before registration.
Target sample size	410

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Nakamura
Organization	Saitama Medical University International Medical Center
Division name	Skin Oncology/Dermatology
Zip code	350-1298
Address	1397-1 Yamane, Hidaka, Saitama, Japan
TEL	042-984-4111
Email	JCOG_sir@ml.jcog.jp

Public contact
Name of contact person	1st name Yasuhiro Middle name Last name Nakamura
Organization	JCOG2005 Coordinating Office
Division name	Department of Skin Oncology/Dermatology, Saitama Medical University International Medical Center
Zip code	350-1298
Address	1397-1 Yamane, Hidaka, Saitama, 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	National Cancer Center Institutional Review Board
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
Tel	03-3542-2511
Email	NCC_IRBoffice@ml.res.ncc.go.jp

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） 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）

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 03 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	2020 Year 12 Month 25 Day
Date of IRB	2021 Year 02 Month 24 Day
Anticipated trial start date	2021 Year 03 Month 03 Day
Last follow-up date	2037 Year 03 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Age-upper limit male:85 years old <= female:90 years old >=

Management information
Registered date	2021 Year 03 Month 03 Day
Last modified on	2021 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049504