UMIN-CTR Clinical Trial

Basic information
Public title	Prospective multicenter study on efficacy of the mediastinal and para-aortic lymph node dissection for esophagogastric junction cancer.
Acronym	Prospective study on efficacy of lymph node dissection for EGJ cancer.
Scientific Title	Prospective multicenter study on efficacy of the mediastinal and para-aortic lymph node dissection for esophagogastric junction cancer.
Scientific Title:Acronym	Prospective study on efficacy of lymph node dissection for EGJ cancer.
Region	Japan

Condition
Condition	Esophagogastric junction cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To invastigate the metastasis rates of mediastinal and para-aortic lymph nodes in the resectable cT2-T4 esophagogastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Metastasis rates of the respective lymph nodes
Key secondary outcomes	Recurrence-free survival, Overall survival, Therapeutic value index calculated by multiplication of the metastasis rate by the 5-year overall survival rate in patients with metastasis in the respective nodes, R0 resection rate, Postoperative complications, Sites of recurrence

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Thorough mediastinal and para-aortic lymph node dissection via a transthoracic approach, or lower mediastinal and para-aortic lymph node dissection via a transhiatal approach
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) An epicenter of tumor locates within 2cm of the esophagogastric junction. 2) Histologicall proven adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma. 3) cT2-T4. 4) Resectable. 5) Age of 20 years or older. 6) ECOG performance status of 0 or 1. 7) Adequate organ function as follows: WBC >=3,000/mm3, Hemoglobin >=8.0 g/dL, Platelet >=75,000/mm3, Total bilirubin <=3.0 mg/dL, Creatinine <=2.0 mg/dL. 8) Written informed consent.
Key exclusion criteria	1) Prior history of gastrectomy. 2) Cannot perform the surgery prerescribed in the protocol.
Target sample size	360

Research contact person
Name of lead principal investigator	1st name Yuichiro Middle name Last name Doki
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	565-0871
Address	2-2-E2, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3251
Email	ydoki@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Yukinori Middle name Last name Kurokawa
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	565-0871
Address	2-2-E2, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3251
Homepage URL
Email	ykurokawa@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Working Group of Japanese Gastric Cancer Association and Japan Esophageal Society
Institute
Department

Funding Source
Organization	Nothing
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	IRB, Osaka University Hospital
Address	2-15, Yamadaoka, Suita, Osaka
Tel	06-6210-8295
Email	rinri@hp-crc.med.osaka-u.ac.jp

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	大阪大学、獨協医科大学、九州がんセンター、大阪府立成人病センター、愛知県がんセンター、四国がんセンター、近畿大学、新潟県立がんセンター新潟病院、徳島大学、千葉大学、群馬大学、鹿児島大学、倉敷中央病院、関西労災病院、静岡県立静岡がんセンター、慶應義塾大学、京都府立医科大学、埼玉県立がんセンター、大阪府立急性期・総合医療センター、東邦大学、京都第一赤十字病院、岐阜大学、神奈川県立がんセンター、岡山大学、名古屋大学、広島市民病院、川崎医科大学、横浜市立大学附属市民総合医療ｾﾝﾀｰ、熊本大学、大阪医療センター、がん研究会有明病院、東京大学、虎の門病院、東京医科歯科大学、国立がん研究センター東病院、北里大学、兵庫医科大学、東海大学、都立駒込病院、埼玉医科大学、自治医科大学、国際医療研究センター

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 20 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	371
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	Main results already published
Date of protocol fixation	2014 Year 02 Month 13 Day
Date of IRB	2014 Year 02 Month 13 Day
Anticipated trial start date	2014 Year 02 Month 21 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 02 Month 20 Day
Last modified on	2020 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015407