Study of S-1 Plus LV for Advanced Gastric Cancer

Phase 2CompletedNCT02090153

Sun Yat-sen University39 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastric Cancer

Interventions

S-1DRUG

40\~60mg bid，d1\~7 q2W

LVDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sun Yat-sen University Cancer Center

Gaungzhou, Guangdong, China

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

The primary endpoint is overall response rate,which equals the rate of patients with CR+PR.

Time frame: 1 year

Secondary Outcomes

Progression free survival (PFS)

Progression-free survival (PFS) was determined from the date of treatment to progression or death

Time frame: 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.

Time frame: 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.

Time frame: 1 year

Disease control rate

Disease control rate equals the rate of patients with CR+PR+SD.

Time frame: 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.

Time frame: 2 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.