ToGA study: A Study of R597 (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer.
Phase 3
- Conditions
- Gastric Cancer
- Registration Number
- JPRN-jRCT2080220186
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
-Male or Female patients (>=18 years of age);
-Inoperable locally advanced, recurrent, or metastatic cancer of the stomach or gastroesophageal junction;
-Adenocarcinoma;
-HER2-positive tumors.
Exclusion criteria:
-Previous chemotherapy for adavanced/metastatic disease;
-Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome;
-History of cardiac deisease;
-Dyspnoea at rest, due to complications of advanced malignancy or other disease, or patients who require supportive oxygen therapy.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method