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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016920
Receipt No. R000018667
Scientific Title A randomized phase II study of systemic chemotherapy with and without trastuzumab followed by surgery in HER2 positive advanced gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis (JCOG1301C:Trigger Study)
Date of disclosure of the study information 2015/03/26
Last modified on 2015/11/27

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Basic information
Public title A randomized phase II study of systemic chemotherapy with and without trastuzumab followed by surgery in HER2 positive advanced gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis (JCOG1301C:Trigger Study)
Acronym A randomized phase II study of systemic chemotherapy with and without trastuzumab followed by surgery in HER2 positive advanced gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis (JCOG1301C:Trigger Study)
Scientific Title A randomized phase II study of systemic chemotherapy with and without trastuzumab followed by surgery in HER2 positive advanced gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis (JCOG1301C:Trigger Study)
Scientific Title:Acronym A randomized phase II study of systemic chemotherapy with and without trastuzumab followed by surgery in HER2 positive advanced gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis (JCOG1301C:Trigger Study)
Region
Japan

Condition
Condition HER2 positive gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis.
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of preoperative chemotherapy with S-1 plus cisplatin (SP) and SP plus trastuzumab for HER2 positive gastric or esophagogastric junction cancer patients with extensive lymph node metastasis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall survival
Key secondary outcomes progression-free survival, response rate of preoperative chemotherapy, proportion of patients with R0 resection, proportion of patients who complete the preoperative chemotherapy and surgery, proportion of patients who complete the protocol treatment, pathological response rate, proportion of adverse events and proportion of severe 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
Medicine Maneuver
Interventions/Control_1 Preoperative chemotherapy with S-1 plus cisplatin followed by D2 or D2+No.16 gastrectomy and postoperative chemotherapy with S-1 treatment for a year.
Interventions/Control_2 Preoperative chemotherapy with trastuzumab combined with S-1 plus cisplatin followed by D2 or D2+No.16 gastrectomy and postoperative chemotherapy with S-1 treatment for a year.
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 primary gastric adenocarcinoma.
2) HER2 positive (IHC 3+ or IHC 2+ and ISH +).
3) Contrast-enhanced abdominal computed tomography (CT) revealed at least one of the following:
i. Para-aortic lymph node enlargement >=1.0 cm in major axis between the upper margin of the celiac artery and the upper border of the inferior mesenteric artery (No. 16a2/ 16b1)
ii. Bulky lymph nodes (>=3 cm 1or>=1.5 cm 2 in major axis) along the celiac, splenic, common or proper hepatic arteries, or the superior mesenteric vein
iii. T2-T4 disease with enlarged regional lymph node (>= 1.5 cm in minor axis)
4) Contrast-enhanced thoracic/abdominal/pelvic CT revealed no metastatic lesion other than the lymph node metastasis.
5) The macroscopic tumor type is neither Borrmann type 4 (linitis plastica) nor large (8 cm or more) type 3
6) No esophageal invasion or an invasion of 3 cm or less
7) No gastric stump cancer
8) No prior chemotherapy, radiotherapy, or endocrine therapy for any malignancies.
9) No prior surgery for gastric carcinoma except bypass surgery and endoscopic resection
10) A staging laparoscopy or laparotomy performed within 28 days before registration revealed negative washing cytology and no peritoneal metastasis
11) Aged 20 to 75 years old.
12) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
13) LVEF (Left ventricular ejection fraction) >= 50% by ultrasound cardiography.
14) Sufficient organ function.
i. Neutrophil >= 1,500/mm3
ii. Hb >= 8.0 g/dL
iii. Platelet >= 100,000/mm3
iv. T.Bil <= 2.0 mg/dL
v. AST <= 100 IU/L
vi. ALT <= 100 IU/L
vii. Creatinin <= 1.3 mg/dL
viii. CCr >= 60mL/min/body
15) Written informed consent.
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Active infection requiring systemic therapy.
3) Body temperature >= 38 degrees Celsius.
4) Pregnancy, possible pregnancy or breastfeeding.
5) Psychiatric disease.
6) Patients requiring systemic steroid medication.
7) Positive HBs antigen
8) Under treatment with flucytosine, phenytoin, or warfarin.
9) Interstitial pneumonia, pulmonary fibrosis or severe emphysema.
10) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months.
11) Poorly controlled hypertension.
12) Poorly controlled diabetes mellitus or routine administration of insulin.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Terashima
Organization Shizuoka Cancer Center
Division name Division of Gastric Surgery
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, 411-8777, Japan
TEL 055-989-5222
Email m.terashima@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Tokunaga
Organization JCOG1301C Coordinating Office
Division name Division of Gastric Surgery, Shizuoka Cancer Center
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, 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 Japan Agency for Medical Research and Development
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
Address
Tel
Email

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)
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)
神奈川県立病院機構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)
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)
大阪府立病院機構大阪府立成人病センター(大阪府)
国立病院機構大阪医療センター(大阪府)
大阪府立病院機構大阪府立急性期・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)
関西医科大学附属枚方病院(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)
天理よろづ相談所病院(奈良県)
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)
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)
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
2015 Year 03 Month 26 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
2014 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 26 Day
Last follow-up date
2023 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Advanced Medical Care B

Management information
Registered date
2015 Year 03 Month 26 Day
Last modified on
2015 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018667

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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