UMIN-CTR Clinical Trial

Basic information
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
Condition	gastric neoplasm
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
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.

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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）

Other administrative information
Date of disclosure of the study information	2005 Year 11 Month 08 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	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
Other related information

Management information
Registered date	2005 Year 11 Month 08 Day
Last modified on	2022 Year 08 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000356