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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036253
Receipt No. R000041060
Scientific Title Randomized controlled phase III trial to evaluate omentum preserving gastrectomy for patients with advanced gastric cancer (JCOG1711, ROAD-GC)
Date of disclosure of the study information 2019/03/19
Last modified on 2019/03/19

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Basic information
Public title Randomized controlled phase III trial to evaluate omentum preserving gastrectomy for patients with advanced gastric cancer (JCOG1711, ROAD-GC)
Acronym Randomized controlled phase III trial to evaluate omentum preserving gastrectomy for patients with advanced gastric cancer (JCOG1711, ROAD-GC)
Scientific Title Randomized controlled phase III trial to evaluate omentum preserving gastrectomy for patients with advanced gastric cancer (JCOG1711, ROAD-GC)
Scientific Title:Acronym Randomized controlled phase III trial to evaluate omentum preserving gastrectomy for patients with advanced gastric cancer (JCOG1711, ROAD-GC)
Region
Japan

Condition
Condition cT3(SS) or cT4a(SE) gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm non-inferiority of omentum preservation compared with omentectomy in relapse-free survival for patients with cT3(SS) or cT4a(SE) gastric cancer in a randomized phase III study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Relapse-free survival
Key secondary outcomes Overall Survival, blood loss, operation time, adverse events

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
Maneuver
Interventions/Control_1 A:omentectomy
Interventions/Control_2 B:omentum preservation
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
79 years-old >=
Gender Male and Female
Key inclusion criteria 1st inclusion criteria (before surgery)
1)Histologically proven gastric adenocarcinoma.
2)Clinical T3/T4 by imaging.
3)cN0-2 H0 P0 M0 and not bulky N2 by contrast-enhanced abdominal computed tomography.
4)Both of HER2 positive and negative patients. HER2 negative has to be confirmed in patients with enlarged lymph node above 15mm in minor axis.
5)Expected R0 surgery
6)Neither Borrmann type 4 nor large (>8cm) type 3
7)Length of esophageal invasion not exceeding 3cm
8)Not stump cancer of stomach
9)Aged between 20 and 79 years old
10)Eastern Cooperative Oncology Group performance status of 0 or 1.
11)No history of upper abdominal surgery or intestinal resection
12)No prior chemotherapy, radiotherapy, or endocrine therapy for any malignancies
13)Adequate organ functions defined as indicated below;
i) WBC of 3,000/mm3 or more
ii) Platelet is 100,000/mm3 or more
iii) T.Bil of 2.0 mg/dL or less
iv) AST of 100 IU/L or less
v) ALT of 100 IU/L or less
vi) Creatinine of 1.5 mg/dL or less
14) Written informed consent

2nd inclusion criteria (during surgery)
1)cT3(SS) or cT4a(SE)
2)cN0-2 H0 P0 M0
3)Expected R0 or R1 only by CY1
4)No need of thoracotomy for resection
5)Expected total resection of omentum
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) malignancies.
2) Infectious disease requiring systemic treatment.
3) Body temperature of 38 degrees Celsius or higher.
4) During pregnancy, within 28 days of postparturition, or during lactation.
5) Severe mental disease.
6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
7) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
8) Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy
9) HIV antibody positive
10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT
Target sample size 1050

Research contact person
Name of lead principal investigator
1st name Takaki
Middle name
Last name Yoshikawa
Organization National Cancer Center Hospital
Division name Gastric Surgery Division
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
TEL 03-3542-2511
Email JCOG_sir@ml.jcog.jp

Public contact
Name of contact person
1st name Takanobu
Middle name
Last name Yamada
Organization JCOG1711 Coordinating Office
Division name Department of Gastrointestinal Surgery, Kanagawa Cancer Center
Zip code 241-8515
Address 2-3-2 Nakao, Asahi-Ku, Yokohama 241-8515, Japan
TEL 045-520-2222
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization National Cancer Center Institutional Review Board
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
Tel 03-3542-2511
Email NCC_IRBoffice@ml.res.ncc.go.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 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)
総合南東北病院(福島県)
栃木県立がんセンター(栃木県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学国際医療センター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(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)
東海大学医学部付属八王子病院(東京都)
神奈川県立がんセンター(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)
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)
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)
大垣市民病院(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)
大阪国際がんセンター(大阪府)
国立病院機構大阪医療センター(大阪府)
大阪急性期・総合医療センター(大阪府)
大阪医科大学(大阪府)
市立豊中病院(大阪府)
堺市立総合医療センター(大阪府)
関西医科大学附属病院(大阪府)
大阪労災病院(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)
和歌山県立医科大学(和歌山県)
島根大学医学部(島根県)
岡山大学病院(岡山県)
広島大学病院(広島県)
広島市立広島市民病院(広島県)
国立病院機構福山医療センター(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)
徳島赤十字病院(徳島県)
香川県立中央病院(香川県)
国立病院機構四国がんセンター(愛媛県)
大分大学医学部附属病院(大分県)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 19 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 Open public recruiting
Date of protocol fixation
2019 Year 01 Month 07 Day
Date of IRB
2019 Year 02 Month 28 Day
Anticipated trial start date
2019 Year 03 Month 19 Day
Last follow-up date
2031 Year 09 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 19 Day
Last modified on
2019 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041060

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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