UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of endoscopic submucosal dissection to expand indication for early gastric cancer (JCOG0607)
Title of the study (Brief title)	Phase II trial of endoscopic submucosal dissection to expand indication for early gastric cancer (JCOG0607)
Region	Japan

Condition
Condition	clinical T1 gastric cancer without submucosal invasion
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of endoscopic submucosal dissection (ESD) for intramucosal gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	5-year overall survival (OS)
Key secondary outcomes	OS in UL(-) cases, OS in UL(+) cases, recurrence-free survival (RFS), 5-year RFS with stomach, proportion of one-piece resection, proportion of pathological curative resection after EMR, adverse events, serious adverse events

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	Endoscopic submucal dissection with or without surgical gastrectomy after histological findings.
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	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically proven differentiated adenocarcinoma by biopsy. A mixed case of undifferentiated components is not eligible. 2) Non-recurrence and single tumor. 3) Clinical T1 tumor without submucosal invasion. 4) Size of tumor is >2cm in a UL(-) case or &#8804;3cm in a UL(+) case. 5) One-piece resection is possible with ESD. 6) The possibility of stenosis after EMR is low. 7) Clinical N0/M0 by abdominal CT. 8) Aged 20 to 75 years old. 9) PS (ECOG) of 0 or 1. 10) No gastrectomy and endoscopic treatment for simultaneous or metachronous gastric cancer, and no reconstructive surgery of stomach tube for esophageal cancer. 11) No prior treatment of chemotherapy (including endocrinotherapy) or radiation therapy against any other malignancies. 12) Sufficient organ functions. 13) Written informed consent.
Key exclusion criteria	1) Impossible to discontinue anticoagulant or antiplatelet medications. 2) Simultaneous or metachronous (within 5 years) double cancers except intramucosal tumor curable with local therapy. 3) Women during pregnancy or breast-feeding. 4) Psychosis. 5) Systemic steroids medication. 6) Active bacterial or fungous infection. 7) History of myocardial infarction or unstable angina pectoris within three months. 8) Uncontrollable hypertension. 9) Uncontrollable diabetes mellitus or administration of insulin. 10) Severe respiratory disease requiring continuous oxygen therapy.
Target sample size	470

Research contact person
Name of lead principal investigator	Narikazu Boku
Organization	Sizuoka Cancer Center
Division name	Division of Gastrointestinal Oncology
Address	1007 Shimonagakubo, Nagaizumi-cho, Shizuoka 411-8777, JAPAN
TEL	055-989-5222
Email

Public contact
Name of contact person	Hiroyuki Ono
Organization	JCOG0607 Coordinating Office
Division name	Division of Endoscopy, Shizuoka Cancer Center
Address	1007 Shimonagakubo, Nagaizumi-cho, Shizuoka 411-8777, JAPAN
TEL	055-989-5222
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
Nationality of Funding Organization	Japan

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

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

北海道大学病院（北海道） 斗南病院（北海道） 岩手県立中央病院（岩手県） 山形県立中央病院（山形県） 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） 自治医科大学（栃木県） 国立がんセンター東病院（千葉県） 国立がんセンター中央病院（東京都） 昭和大学病院（東京都） 癌研究会有明病院（東京都） 虎の門病院（東京都） 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） 北里大学医学部（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） 石川県立中央病院（石川県） 佐久総合病院（長野県） 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） 愛知県がんセンター愛知病院（愛知県） 京都大学医学部附属病院（京都府） 大阪府立病院機構大阪府立成人病センター（大阪府） 大阪医科大学（大阪府） 神戸大学医学部（兵庫県） 兵庫県立がんセンター（兵庫県） 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）

Other administrative information
Date of disclosure of the study information	2007 Year 06 Month 08 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2007 Year 04 Month 25 Day
Anticipated trial start date	2007 Year 06 Month 01 Day
Last follow-up date	2014 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/28224238
Results	See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html
Other related information

Management information
Registered date	2007 Year 06 Month 08 Day
Last modified on	2017 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000885