Study of S-1 Plus LV for Advanced Gastric Cancer
- Registration Number
- NCT02090153
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- histologically confirmed metastatic or recurrent gastric cancer
- with at least one measurable lesion by RECIST criteria
- an age of ≥ 18
- adequate oral intake
- no previous radiotherapy, immunotherapy, biotherapy, hormonotherapy and chemotherapy within 5 years (adjuvant chemotherapy without S-1 was allowed if finished 6 months before enrollment)
- an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- adequate bone marrow function, hepatic function and renal functions
- a history of hypersensitivity to S-1 or LV, usage of drugs interacting with S-1
- serious concomitant conditions (severe heart disease, pulmonary fibrosis, intestinal obstruction, enteroplegia, renal failure, liver failure, pre-existing sensory neuropathy ≥ grade 2, uncontrolled infections, psychogenic disorders, human immunodeficiency virus infection, severe diarrhea, nausea, or vomiting, severe ascites or pleural effusion, etc.)
- extensive bone metastasis, brain metastasis or meningeal metastasis
- another synchronous cancer
- surgery within 3 weeks before enrollment
- participating in other clinical studies
- women who were or to be pregnant, nursing infants, and men who were to conceive children
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description S-1 plus LV S-1 All patients 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. S-1 plus LV LV All patients 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.
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) 1 year The primary endpoint is overall response rate,which equals the rate of patients with CR+PR.
- Secondary Outcome Measures
Name Time Method Progression free survival (PFS) 1-1.5 years Progression-free survival (PFS) was determined from the date of treatment to progression or death
Overall survival (OS) 1-2.5 years Overall survival (OS) was calculated from the date of treatment to death from any cause or the last date of follow-up.
Time to treatment failure (TTF) 1 year Time to treatment failure (TTF) was determined from the date of treatment to progression, death, refusal or interruption due to adverse events.
Disease control rate 1 year Disease control rate equals the rate of patients with CR+PR+SD.
Adverse Events (AEs) 2 year All treatment-related adverse events (AEs) were categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Gaungzhou, Guangdong, China