Study of S-1 Plus LV for Advanced Gastric Cancer

March 14, 2014 updated by: Ruihua Xu, Sun Yat-sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Gaungzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Taiho Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: ruihua xu, Professor, SunYat-sen University Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Estimate)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL for AGC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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