A Randomized, Open-label Study of the Effect of First-line Herceptin in Combination With a Fluoropyrimidine and Cisplatin Versus Chemotherapy Alone on Overall Survival in Patients With HER2-positive Advanced Gastric Cancer
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Gastric Cancer
Both
Gastric Cancer
Trial Information
A Randomized, Open-label Study of the Effect of First-line Herceptin in Combination With a Fluoropyrimidine and Cisplatin Versus Chemotherapy Alone on Overall Survival in Patients With HER2-positive Advanced Gastric Cancer
Inclusion Criteria:
- Adult patients >=18 years of age
- Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or
gastro-esophageal junction
- Adenocarcinoma
- HER2-positive tumors
Exclusion Criteria:
- Previous chemotherapy for advanced/metastatic disease
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption
syndrome
- History of cardiac disease
- Dyspnoea at rest, due to complications of advanced malignancy or other disease, or
patients who require supportive oxygen therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival\n
Outcome Time Frame:
Through study completion
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Australia: National Health and Medical Research Council
Study ID:
BO18255
NCT ID:
NCT01041404
Start Date:
September 2005
Completion Date:
June 2010
Related Keywords:
- Gastric Cancer
- Stomach Neoplasms
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