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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013205
Receipt No. R000015407
Scientific Title Prospective multicenter study on efficacy of the mediastinal and para-aortic lymph node dissection for esophagogastric junction cancer.
Date of disclosure of the study information 2014/02/20
Last modified on 2020/02/25

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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/ctr_e/ctr_view.cgi?recptno=R000015407

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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