UMIN-CTR Clinical Trial

Public title

Randomized phase III trial of surgery plus neoadjubant TS-1 and cisplatin compared with surgery alone for type 4 and large type 3 gastric cancer: Japan Clinical Oncology Group Study (JCOG 0501)

Acronym

Randomized phase III trial of surgery plus neoadjubant TS-1 and cisplatin compared with surgery alone for type 4 and large type 3 gastric cancer: Japan Clinical Oncology Group Study (JCOG 0501)

Scientific Title

Randomized phase III trial of surgery plus neoadjubant TS-1 and cisplatin compared with surgery alone for type 4 and large type 3 gastric cancer: Japan Clinical Oncology Group Study (JCOG 0501)

Scientific Title:Acronym

Randomized phase III trial of surgery plus neoadjubant TS-1 and cisplatin compared with surgery alone for type 4 and large type 3 gastric cancer: Japan Clinical Oncology Group Study (JCOG 0501)

Region

Japan

Condition

gastric neoplasm

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tumor in comparison with surgery with TS-1 as an adjuvant chemotherapy.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

overall survival

Key secondary outcomes

progression free survival (PFS), response rate, proportion of protocol achievement, proportion of curative resection, and adverse events.
In this trial, curative resection means R0 resection (TNM classification) with more than D2 dissection.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Maneuver

Interventions/Control_1

Gastrectomy with more than D2 disseciton + adjuvant chemotherpy(TS-1)

Interventions/Control_2

Neoadjubant chemotherpy(TS-1+CDDP) followed by gastrectomy + adjuvant chemotherpy(TS-1)

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) histologically proven adenocarcionoma of stomach
(2) Borrmann type 4 or large (>=8 cm) type 3
(3) no evidence of distant metastasis including liver(M0)
(4) macroscopic curative resection is judged as possible
(5) no evidence of a macroscopic unresectable factor with laparoscopic confirmation. Dissemination to peritoneal surfaces adjacent to stomach (above the transverse colon, including omentum) and/or positive peritoneal lavage cytology is eligible.
(6) no involvement of the esophagus with > 3cm
(7) an age of 20-75 years
(8) an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
(9) no prior chemotherapy, radiotherapy for any malignancy
(10) no prior surgery for gastric cancer except for endoscopic membrane resection (EMR)
(11) no breeding from primary tumor or gastrointestinal stenosis
(12) sufficient oral intake
(13) adequate organ function
(14) written informed consent

Key exclusion criteria

(1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
(2) pregnant or breast-feeding women
(3) severe mental disease
(4) systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
(5) other severe complications such as paralytic ileus, intensitinal pneumonitis, pulumonary fibrosis, or ischemic heart disease
(6) myocardial infarction within six disease-free months
(7) positive HBs antigen

Target sample size

316

Name of lead principal investigator

1st name
Middle name
Last name	Mitsuru Sasako, MD, PhD

Organization

Hyogo College of Medicine

Division name

Upper GI Surgery Division

Zip code

Address

1-1, Mukogawa-cho, Nishinomiya, 663-8501, JAPAN

TEL

0798-45-6767

Email

msasako@hyo-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Yoshiaki Iwasaki, MD, PhD.

Organization

JCOG0501 Coordinating Office

Division name

Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Zip code

Address

3-18-22 Hon-komagome, Bunkyo-ku, Tokyo 113-8677, Japan

TEL

03-3823-2101

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

Japanese Governmental office

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）
国立病院機構仙台医療センター（宮城県）
宮城県立がんセンター（宮城県）
山形県立中央病院（山形県）
栃木県立がんセンター（栃木県）
防衛医科大学校（埼玉県）
埼玉県立がんセンター（埼玉県）
国立がん研究センター東病院（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）
都立墨東病院（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）
新潟県立がんセンター新潟病院（新潟県）
新潟県厚生連長岡中央綜合病院（新潟県）
燕労災病院（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）
岐阜市民病院（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）
名古屋大学医学部（愛知県）
国立病院機構京都医療センター（京都府）
京都第2赤十字病院（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）
大阪医科大学（大阪府）
市立豊中病院（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）
神戸大学医学部（兵庫県）
関西労災病院（兵庫県）
兵庫医科大学（兵庫県）
兵庫県立がんセンター（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）
島根大学医学部（島根県）
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）
福山市民病院（広島県）
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

2005

Year

11

Month

08

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

Completed

Date of protocol fixation

2005

Year

09

Month

16

Day

Date of IRB

2005

Year

11

Month

01

Day

Anticipated trial start date

2005

Year

10

Month

17

Day

Last follow-up date

2017

Year

11

Month

17

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2005

Year

11

Month

08

Day

Last modified on

2022

Year

08

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000356