Study of S-1 Plus LV for Advanced Gastric Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: S-1
* Drug: LV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-1 plus LV<br>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. | Drug: S-1<br>* 40 60mg bid，d1 7 q2W<br>* Other names: tegafur/gimeracil/oteracil potassium;Drug: LV<br>* LV is given simultaneously at a ﬁxed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest.<br>* Other names: Leucovorin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | The primary endpoint is overall response rate,which equals the rate of patients with CR+PR. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | Progression-free survival (PFS) was determined from the date of treatment to progression or death | 1-1.5 years | 
| Overall survival (OS) | Overall survival (OS) was calculated from the date of treatment to death from any cause or the last date of follow-up. | 1-2.5 years | 
| Time to treatment failure (TTF) | Time to treatment failure (TTF) was determined from the date of treatment to progression, death, refusal or interruption due to adverse events. | 1 year | 
| Disease control rate | Disease control rate equals the rate of patients with CR+PR+SD. | 1 year | 
| Adverse Events (AEs) | All treatment-related adverse events (AEs) were categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events. | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advance Gastric Cancer,, S-1 plus leucovorin,, ORR,, OS,, TTP,, TTF,, Adverse events,, Pharmacokinetics