UMIN-CTR Clinical Trial

Basic information
Public title	Single-arm phase III confirmatory trial on indications of endoscopic submucosal dissection for elderly patients with early gastric cancer. (JCOG1902, Elderly G-ESD study)
Acronym	Single-arm phase III confirmatory trial on indications of endoscopic submucosal dissection for elderly patients with early gastric cancer. (JCOG1902, Elderly G-ESD study)
Scientific Title	Single-arm phase III confirmatory trial on indications of endoscopic submucosal dissection for elderly patients with early gastric cancer.
Scientific Title:Acronym	Single-arm phase III confirmatory trial on indications of endoscopic submucosal dissection for elderly patients with early gastric cancer.
Region	Japan

Condition
Condition	Clinical T1a (M) or T1b (SM) early gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm non-inferiority of overall survival of initial endoscopic submucosal dissection (ESD) followed by watchful waiting or additional gastrectomy according to the risk of lymph node metastases pathologically assessed after ESD, compared with standard gastrectomy for elderly patients with early gastric cancer for which absolute or expanded indication of endoscopic resection in Japanese gastric cancer treatment guidelines 2018 ver.5 cannot be applied.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	5-year overall survival in patients with curability 1 for the elderly (EL-1), 5-year overall survival in all eligible patients
Key secondary outcomes	55-year relapse-free survival, 5-year major relapse-free survival, 5-year survival without either recurrence or gastrectomy, 5-year overall survival in patients with curability 3 for the elderly (EL-3), proportion of en bloc resection with ESD, curability of ESD (eCuraA･eCuraB･EL-1･EL-2･EL-3), adverse events, Instrumental Activities of Daily Living (IADL)

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: Endoscopic submucosal dissection (ESD) Additional gastrectomy for patients with EL-3
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Clinical T1a (M) or T1b (SM) early gastric cancer (GC) 2) Confirmed by endoscopic and pathological assessment as follows: i) in case of T1b (SM), histologically proven adenocarcinoma, carcinoma with lymphoid stroma, or adenocarcinoma of fundic gland type and the size of tumor (SOT) is <= 3cm. UL is not considered. ii) in case of T1a (M), histologically proven adenocarcinoma, carcinoma with lymphoid stroma, or adenocarcinoma of fundic gland type with components of undifferentiated adenocarcinoma (por, sig, muc) and 1. UL0, SOT is > 2 cm and <= 3cm or 2. UL1, SOT is <= 3cm 3) Expected en bloc endoscopic resection with negative margin 4) Confirmation of the horizontal margin by cancer-free endoscopic biopsy around the lesion with components of undifferentiated adenocarcinoma. 5) In case of T1b (SM), resectable lesion with negative vertical margin confirmed by endoscopic ultrasonography. 6) Initial and single GC. Metachronous GC is eligible only when the scar after endoscopic resection with eCuraA or eCuraB is away from the lesion. 7) Clinical N0 and M0 by contrast enhanced abdominal CT. 8) Low risk of stenosis after ESD, meeting both criteria below: i) No invasion of proximal edge of tumor to esophagogastric junction ii) No invasion of distal edge of tumor to pylorus 9) No prior gastrectomy and no prior reconstructive surgery of stomach tube for esophageal cancer. 10) No prior abdominal radiotherapy for any cancers. 11) Male aged 75 years old or older, Female aged 80 years old or older 12) ECOG PS of 0 or 1 13) Patients who are operable 14) Patients who are informed by a surgeon that gastrectomy is a standard treatment 15) No dementia 16) Adequate organ functions defined as; i) WBC of 3,000/mm3 or more, and 12,000/mm3 or less ii) Hemoglobin of 9.0 g/dL or more iii) Platelet count 100,000/mm3 or more iv) T.Bil of 2.0 mg/dL or less v) AST of 100 U/L or less vi) ALT of 100 U/L or less vii) Creatinine of 2.0 mg/dL or less 17) Written informed consent
Key exclusion criteria	1) Synchronous or metachronous (within 5 years) malignancies. 2) Infectious disease requiring systemic treatment. 3) Body temperature of 38 degrees Celsius or higher. 4) Severe mental disease. 5) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 6) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. 7) Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy 8) Poorly controlled hypertension 9) Poorly controlled diabetes despite continuous use of insulin 10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest computed tomography 11) Impossible to suspend anticoagulant or antiplatelet medications or substitute aspirin or cilostazol for them. 12) HIV antibody positive
Target sample size	325

Research contact person
Name of lead principal investigator	1st name Ichiro Middle name Last name Oda
Organization	National Cancer Center Hospital
Division name	Endoscopy Division
Zip code	104-0045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Email	JCOG_sir@ml.jcog.jp

Public contact
Name of contact person	1st name Masau Middle name Last name Sekiguchi
Organization	JCOG1902 Coordinating Office
Division name	Endoscopy Division, National Cancer Center Hospital
Zip code	104-0045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
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

宮城県立がんセンター（宮城県） 東北大学病院（宮城県） 国立病院機構仙台医療センター（宮城県） 山形県立中央病院（山形県） 福島県立医科大学附属病院（福島県） 総合南東北病院（福島県） 茨城県立中央病院・茨城県地域がんセンター（茨城県） 栃木県立がんセンター（栃木県） 群馬大学医学部附属病院（群馬県） 千葉県がんセンター（千葉県） 国立がん研究センター東病院（千葉県） 虎の門病院（東京都） 慶應義塾大学病院（東京都） 都立墨東病院（東京都） がん研究会有明病院（東京都） 昭和大学病院（東京都） NTT東日本関東病院（東京都） 国立がん研究センター中央病院（東京都） 東京医科歯科大学（東京都） 横浜市立大学附属市民総合医療センター（神奈川県） 北里大学医学部（神奈川県） 神奈川県立がんセンター（神奈川県） 横浜市立市民病院（神奈川県） 新潟県立がんセンター新潟病院（新潟県） 新潟大学医歯学総合病院（新潟県） 富山県立中央病院（富山県） 石川県立中央病院（石川県） 佐久総合病院佐久医療センター（長野県） 岐阜市民病院（岐阜県） 静岡県立静岡がんセンター（静岡県） 静岡県立総合病院（静岡県） 愛知県がんセンター（愛知県） 名古屋市立大学病院（愛知県） 京都府立医科大学（京都府） 国立病院機構京都医療センター（京都府） 京都大学医学部附属病院（京都府） 大阪労災病院（大阪府） 大阪医科大学（大阪府） 大阪赤十字病院（大阪府） 大阪急性期・総合医療センター（大阪府） 大阪市立大学医学部附属病院（大阪府） 大阪市立総合医療センター（大阪府） 大阪国際がんセンター（大阪府） 国立病院機構大阪医療センター（大阪府） 大阪大学医学部（大阪府） 兵庫医科大学（兵庫県） 兵庫県立がんセンター（兵庫県） 関西労災病院（兵庫県） 市立伊丹病院（兵庫県） 日本赤十字社和歌山医療センター（和歌山県） 島根県立中央病院（島根県） 岡山大学病院（岡山県） 広島市立広島市民病院（広島県） 広島市立安佐市民病院（広島県） 広島大学病院（広島県） 徳島赤十字病院（徳島県） 国立病院機構四国がんセンター（愛媛県） 高知医療センター（高知県） 大分大学医学部附属病院（大分県）

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 07 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 01 Month 31 Day
Date of IRB	2020 Year 03 Month 25 Day
Anticipated trial start date	2020 Year 04 Month 07 Day
Last follow-up date	2029 Year 04 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 04 Month 07 Day
Last modified on	2020 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045608