ToGA clinical trial design
ToGA is an ongoing Phase III, randomised, open-label, multicentre study evaluating the efficacy and safety of Herceptin in combination with a fluoropyrimidine (Xeloda or 5-fluorouracil at the investigator’s discretion) and cisplatin versus chemotherapy alone as first-line therapy in patients with HER2-positive advanced gastric cancer.
ToGA trial design
Endpoints
- Primary: overall survival.
- Secondary: progression-free survival, overall response rate, clinical benefit rate, duration of response, safety profile, quality of life and pharmacokinetics of Herceptin.
Inclusion criteria
- Male or female adult patients (>18 years) with advanced HER2-positive gastric cancer (inoperable locally advanced, recurrent and/or metastatic disease).
- Histologically confirmed adenocarcinoma of stomach or gastro-oesophageal junction.
- Left ventricular ejection fraction >50%.
- No previous treatment for advanced/metastatic disease.
Participating countries
- Australia, China, the EU, India, Japan, Korea, Latin America, Russia, South Africa, Taiwan, Turkey.