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Brief Title: Study of S-1 Plus LV for Advanced Gastric Cancer
Official Title: Phase II Study of S-1 Plus Leucovorin (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic and Recurrent Gastric Cancer
Study ID: NCT02090153
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of S-1 plus Leucovorin (1 week on and 1 week off) as first-line treatment for patients with metastatic and recurrent gastric cancer.
Detailed Description: Patients enrolled in this study were orally treated with S-1 in doses of 40 mg (body surface area (BSA)\<1.25 m2), 50 mg (1.25≤BSA\<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks. Treatment was continued until progressive disease (PD), unacceptable toxicity or patient refusal.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sun Yat-sen University Cancer Center, Gaungzhou, Guangdong, China
Name: Ruihua Xu, Professor
Affiliation: SunYat-sen University Cancer Center
Role: PRINCIPAL_INVESTIGATOR