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)
- Conditions
- HER2 positive gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis.
- Registration Number
- JPRN-UMIN000016920
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 130
Not provided
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.
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.