UMIN-CTR Clinical Trial

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

Clinical T1a (M) or T1b (SM) early gastric cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2020

Year

04

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2020

Year

04

Month

07

Day

Last modified on

2020

Year

04

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045608