Study of S-1 Plus LV for Advanced Gastric Cancer

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT02090153

Collaborator

Taiho Pharmaceutical Co., Ltd. (Industry)

Enrollment

Location

Arm

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: S-1 Drug: LV	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: S-1 plus 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.

Drug: S-1

40~60mg bid，d1~7 q2W

Other Names:

tegafur/gimeracil/oteracil potassium

Drug: LV

LV is given simultaneously at a ﬁxed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest.

Other Names:

Leucovorin

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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