UMIN-CTR Clinical Trial

Public title

Nonrandomized confirmatory study of laparoscopy assisted total gastrectomy and proximal gastrectomy with nodal dissection
for clinical stage I gastric cancer (JCOG1401, cSt-I GC LATG PG sP3)

Acronym

Nonrandomized confirmatory study of laparoscopy assisted total gastrectomy and proximal gastrectomy with nodal dissection
for clinical stage I gastric cancer (JCOG1401, cSt-I GC LATG PG sP3)

Scientific Title

Nonrandomized confirmatory study of laparoscopy assisted total gastrectomy and proximal gastrectomy with nodal dissection
for clinical stage I gastric cancer (JCOG1401, cSt-I GC LATG PG sP3)

Scientific Title:Acronym

Nonrandomized confirmatory study of laparoscopy assisted total gastrectomy and proximal gastrectomy with nodal dissection
for clinical stage I gastric cancer (JCOG1401, cSt-I GC LATG PG sP3)

Region

Japan

Condition

gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To demonstrate the safety of laparoscopy assisted total gastrectomy (LATG) or laparoscopy assisted proximal gastrectomy (LAPG) with nodal dissection for clinical T1N0, T1N+ or T2N0 gastric cancer which is not indicated for EMR/ESD.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

Proportion of anastomotic leak

Key secondary outcomes

Overall survival, relapse-free survival, proportion of LATG or LAPG completion, proportion of conversion to open surgery, adverse events, and short-term clinical outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

LATG or LAPG with nodal dissection with D1, D1+ or D2 lymph node dissection

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

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Histologically proven gastric adenocarcinoma.
2) Clinical stage T1N0, T1N(+)*, or T2N0 according to the 14th edition of Japanese Classification of Gastric Carcinoma (3rd English edition).
*T1N(+) corresponds to T1N1 according to the 13th edition of Japanese Classification of Gastric Carcinoma (2nd English edition).
3) In case of T2N0, tumor does not involve greater curvature
4) In case without preceding endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), either 'cN(+)' or 'cN0 and no indication of EMR or ESD' is eligible.
5) In case with preceding EMR or ESD, the following conditions are all fulfilled:
i) pathological findings require additional gastrectomy
ii) within 91 days from EMR or ESD
iii) no perforation by EMR or ESD
6) R0 resection is expected by total gastrectomy or proximal gastrectomy.
7) No invasion to duodenum or esophagus.
8) Aged 20 to 80 years.
9) PS (ECOG) of 0 or 1.
10) Body mass index less than 30.
11) No history of upper abdominal surgery and no history of intestinal resection except for appendectomy.
12) No prior treatment of chemotherapy or radiation therapy against any other malignancies. History of hormone therapy after more than 1 year from the last administration is eligible.
13) Sufficient organ functions.
i. WBC >= 3,000/mm3
ii. Platelet >= 100,000/mm3
iii. T.Bil =< 2.0 mg/dL
iv. AST =< 100 IU/L
v. ALT =< 100 IU/L
vi. Creatinine =< 1.5 mg/dL
14) Written informed consent.

Key exclusion criteria

1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Infectious disease with systemic therapy indicated.
3) Body temperature of 38 or more degrees Celsius.
4) Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding.
5) Severe psychiatric disease.
6) Continuous systemic steroid or immune-suppressive drug therapy.
7) Unstable angina pectoris, or history of myocardial infarction within six months.
8) Poorly controlled hypertension.
9) Poorly controlled diabetes mellitus in spite of continuous use of insulin.
10) Severe respiratory disease requiring continuous oxygen therapy.

Target sample size

245

Name of lead principal investigator

1st name
Middle name
Last name	Hitoshi Katai

Organization

National Cancer Center Hospital

Division name

Gastric Surgery Division

Zip code

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN

TEL

03-3542-2511

Email

hkatai@ncc.go.jp

Name of contact person

1st name
Middle name
Last name	Hitoshi Katai

Organization

JCOG1401 Coordinating Office

Division name

Gastric Surgery Division, National Cancer Center Hospital

Zip code

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, 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

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

函館厚生院函館五稜郭病院（北海道）
恵佑会札幌病院（北海道）
岩手医科大学（岩手県）
山形県立中央病院（山形県）
栃木県立がんセンター（栃木県）
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）
国立がん研究センター東病院（千葉県）
千葉県がんセンター（千葉県）
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）
東京医科歯科大学（東京都）
がん研究会有明病院（東京都）
虎の門病院（東京都）
神奈川県立病院機構神奈川県立がんセンター（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
新潟県厚生連長岡中央綜合病院（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）
岐阜大学医学部（岐阜県）
静岡県立総合病院（静岡県）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター中央病院（愛知県）
国立病院機構京都医療センター（京都府）
大阪大学医学部（大阪府）
近畿大学医学部（大阪府）
大阪府立病院機構大阪府立成人病センター（大阪府）
国立病院機構大阪医療センター（大阪府）
大阪府立病院機構大阪府立急性期・総合医療センター（大阪府）
市立堺病院（大阪府）
関西医科大学附属枚方病院（大阪府）
大阪労災病院（大阪府）
神戸大学医学部（兵庫県）
関西労災病院（兵庫県）
市立伊丹病院（兵庫県）
天理よろづ相談所病院（奈良県）
和歌山県立医科大学（和歌山県）
岡山大学病院（岡山県）
広島大学病院（広島県）
福山市民病院（広島県）
徳島赤十字病院（徳島県）
大分大学医学部附属病院（大分県）

Date of disclosure of the study information

2015

Year

04

Month

17

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

Main results already published

Date of protocol fixation

2015

Year

02

Month

23

Day

Date of IRB

2015

Year

04

Month

06

Day

Anticipated trial start date

2015

Year

04

Month

17

Day

Last follow-up date

2023

Year

04

Month

17

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

04

Month

17

Day

Last modified on

2021

Year

01

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019757