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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040083
Receipt No. R000045608
Scientific Title Single-arm phase III confirmatory trial on indications of endoscopic submucosal dissection for elderly patients with early gastric cancer.
Date of disclosure of the study information 2020/04/07
Last modified on 2020/04/07

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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