Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer

An Open-label, Multicenter, Randomized, 3 Arm Study of S-1 Compared With S-1/CDDP, or S-1/CDDP Compared With 5-FU/CDDP in Patients With Advanced Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00202969

Enrollment

180

Registered

2005-09-20

Start date

2005-07-31

Completion date

2007-06-30

Last updated

2011-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Stomach cancer

Brief summary

This is an open-label, multicenter, three arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1 alone compared with S-1 plus CDDP, and S-1 plus CDDP compared with 5-FU plus CDDP in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1:1) to S-1 (Arm A), S-1/CDDP (Arm B) or 5-FU/CDDP (Arm C). Patients will be stratified to achieve balanced distribution of patients to each arm according to following stratifications, performance status (0, 1, or 2), the number of metastatic sites (1 vs \>1), prior gastrectomy, and center.

Interventions

DRUGS-1

S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 28 repeated 6 weeks.

DRUGS-1 plus CDDP

S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 21 with a single dose of CDDP 60 mg/m2 will be administered as an 1- to 3-hour IV infusion following the morning dose of S-1 on Day 8. The combination therapy will be repeated every 5 weeks.

DRUG5-FU plus CDDP

5-FU 600 mg/m2/24 hours administered intravenously as a CI over 120 hours (Days 1 through 5) along with a 30-minute infusion CDDP 20 mg/m2 from Day 1 through Day 5. The control treatment arm will be repeated every 4 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Non-prior chemotherapy treated advanced gastric adenocarcinoma * Age 18 and over * Performance status 0, 1, or 2 (ECOG) * Life expectancy 3 months * Hematopoietic WBC lower limit of normal-12,000/mm\^3 Absolute granulocyte count ≥ 2,000/mm\^3 Platelet count ≥ 100,000/mm\^3 Hemoglobin ≥ 8.0 g/dL * Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL * Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 60 mL/min

Exclusion criteria

* Interstitial pneumonia, pulmonary fibrosis * Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure * Intestinal paralysis, intestinal obstruction, uncontrollable diabetes

Design outcomes

Primary

Measure	Time frame
Response rate	every course for first three courses, then every other course

Secondary

Measure	Time frame
Safety profile, time to treatment failure	any time

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026