UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016920 |
|---|---|
| Receipt number | 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 10:40:04 |
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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
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/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018667
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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