JCOG1301C: 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
- Conditions
- Gastric cancer
- Registration Number
- JPRN-jRCTs031180006
- Lead Sponsor
- TERASHIMA Masanori
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 130
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 1 or >=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 (>= 0.9 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)When inclusion criteria 3)-i or 3)-ii is satisfied, a staging laparoscopy or laparotomy performed within 28 days before registration reveale negative washing cytology and no peritoneal metastasis
11) Aged 20 to 75 years old (except for patients who do not satisfy inclusion criteria 3-)i nor 3)-ii whose upper age limit is 79 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. Creatinine <= 1.3 mg/dL
viii. CCr >= 60mL/min/body
15) Written informed consent.
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 or a history of myocardial infarction within 6 months.
11) Poorly controlled hypertension.
12) Poorly controlled diabetes mellitus or routine administration of insulin.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method 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.