Study of S-1 Plus LV for Advanced Gastric Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-03-31

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.

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

S-1

Intervention Type DRUG

40\~60mg bid，d1\~7 q2W

LV

Intervention Type DRUG

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

Interventions

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S-1

40\~60mg bid，d1\~7 q2W

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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tegafur/gimeracil/oteracil potassium Leucovorin

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No