Unique ID issued by UMIN | UMIN000024065 |
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Receipt number | R000027564 |
Scientific Title | Phase III trial to evaluate the efficacy of neoadjuvant chemotherapy with S-1 plus oxaliplatin followed by D2 gastrectomy with adjuvant S-1 in locally advanced gastric cancer.(JCOG1509, NAGISA trial) |
Date of disclosure of the study information | 2016/09/15 |
Last modified on | 2018/09/05 11:15:18 |
Phase III trial to evaluate the efficacy of neoadjuvant chemotherapy with S-1 plus oxaliplatin followed by D2 gastrectomy with adjuvant S-1 in locally advanced gastric cancer.(JCOG1509, NAGISA trial)
Phase III trial to evaluate the efficacy of neoadjuvant chemotherapy with S-1 plus oxaliplatin followed by D2 gastrectomy with adjuvant S-1 in locally advanced gastric cancer.(JCOG1509, NAGISA trial)
Phase III trial to evaluate the efficacy of neoadjuvant chemotherapy with S-1 plus oxaliplatin followed by D2 gastrectomy with adjuvant S-1 in locally advanced gastric cancer.(JCOG1509, NAGISA trial)
Phase III trial to evaluate the efficacy of neoadjuvant chemotherapy with S-1 plus oxaliplatin followed by D2 gastrectomy with adjuvant S-1 in locally advanced gastric cancer.(JCOG1509, NAGISA trial)
Japan |
Gastric cancer
Gastrointestinal surgery |
Malignancy
YES
To confirm the superiority of preoperative chemotherapy with S-1 plus oxaliplatin followed by surgery and postoperative chemotherapy to surgery and postoperative chemotherapy for clinical T3-4N1-3M0 gastric cancer patients.
Efficacy
Confirmatory
Phase III
Overall survival
Progression-free survival, response rate of preoperative chemotherapy by RECIST ver1.0, proportion of R0 resection, proportion of completion of surgery, proportion of completion of protocol treatment, pathological response rate, toxicities, dose intensity of preoperative chemotherapy, proportion of patients undergoing postoperative chemotherapy at 3, 6, 9, and 12 months after surgery
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Arm A: gastrectomy with D2 lymph node dissection and postoperative chemotherapy with S-1 for one year
Arm B: preoperative chemotherapy with S-1 (80-120 mg/body, p.o., day 1-14) plus oxaliplatin (130 mg/m2, IV, day 1,) followed by gastrectomy with D2 lymph node dissection and postoperative chemotherapy with S-1 for one year
20 | years-old | <= |
79 | years-old | >= |
Male and Female
1) Histologically proven gastric adenocarcinoma.
2) Clinical T3/T4 by imaging.
3) No tumor invasion to pancreas head from primary tumor and/or metastatic lymph node
4) Enlarged lymph node (>=8mm in minor axis or >=10mm in major axis) by contrast-enhanced abdominal computed tomography (CT).
5) No bulky lymph nodes (>=3 cm x 1 or >=1.5 cm x 2 in major axis) along the celiac, splenic, common or proper hepatic arteries, or the superior mesenteric vein by contrast-enhanced abdominal computed tomography.
6) Both of HER2 positive and negative patients. HER2 negative has to be confirmed in patients with enlarged lymph node of 15mm in minor axis.
7) No distant metastasis based on contrast-enhanced thoracic/abdominal/pelvic CT.
8) The macroscopic tumor type is neither Borrmann type 4 (linitis plastica) nor large (8 cm or more) type 3.
9) No esophageal invasion or an invasion of 3 cm or less.
10) No gastric stump cancer.
11) When a staging laparoscopy is performed before registration, non-curable factors other than positive lavage cytology are not revealed.
12) Sufficient oral intake.
13) No prior chemotherapy, radiotherapy, or endocrine therapy for any malignancies within five years.
14) Aged between 20 and 79 years old.
15) Eastern Cooperative Oncology Group performance status of 0 or 1.
16) 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. Creatinine <= 1.3 mg/dL
viii. CCr >= 60mL/min/body
17) Written informed consent.
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) Under treatment with flucytosine, phenytoin, or warfarin.
8) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
9) Poorly controlled diabetes.
10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT.
470
1st name | |
Middle name | |
Last name | Masanori Terashima |
Shizuoka Cancer Center
Division of Gastric Surgery
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan
055-989-5222
m.terashima@scchr.jp
1st name | |
Middle name | |
Last name | Masanori Tokunaga |
JCOG1509 Coordinating Office
Division of Gastric Surgery, Shizuoka Cancer Center
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan
055-989-5222
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Japan Clinical Oncology Group (JCOG)
Japan Agency for Medical Research and Development
Other
Japan
NO
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)
2016 | Year | 09 | Month | 15 | Day |
Unpublished
Open public recruiting
2016 | Year | 06 | Month | 30 | Day |
2016 | Year | 09 | Month | 15 | Day |
2026 | Year | 03 | Month | 15 | Day |
2016 | Year | 09 | Month | 15 | Day |
2018 | Year | 09 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027564
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