UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013205 |
|---|---|
| Receipt number | 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 16:17:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ykurokawa@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Working Group of Japanese Gastric Cancer Association and Japan Esophageal Society
Institute
Department
Personal name
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
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
Value
https://center6.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 |
