Gastric Cancer
Conditions
Keywords
Advance Gastric Cancer,, S-1 plus leucovorin,, ORR,, OS,, TTP,, TTF,, Adverse events,, Pharmacokinetics
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.
Interventions
DRUGS-1
40\ 60mg bid，d1\ 7 q2W
DRUGLV
LV is given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest.
Sponsors
Taiho Pharmaceutical Co., Ltd.
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | 1 year | The primary endpoint is overall response rate,which equals the rate of patients with CR+PR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed