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Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial

NCT01285557 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 361

Last updated 2024-09-19

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and gastro-esophageal junction cancer previously untreated with chemotherapy.

Conditions

  • Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction

Interventions

DRUG

S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm)

25 mg/m² body surface area (BSA) orally 2 times daily from Days 1 through 21 followed by a 7 day rest period, plus cisplatin 75 mg/m2 BSA on Day 1 each 28 day cycle Number of Cycles: until progression or unacceptable toxicity develops. Treatment with cisplatin is limited to a maximum of 8 cycles.

DRUG

Fluorouracil/cisplatin (control arm)

5-FU: 800 mg/m2 BSA/24 hours by continuous intravenous infusion (CIV) from Days 1 through 5 plus cisplatin 80 mg/m2 BSA on Day 1 each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. Treatment with cisplatin is limited to a maximum of 8 cycles.

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Taiho Central · Taiho Oncology, Inc. USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-14
Primary Completion
2014-08-15
Completion
2014-08-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Bulgaria
  • Croatia
  • Estonia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Poland
  • Portugal
  • Romania
  • Russia
  • South Africa
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01285557 on ClinicalTrials.gov