Overview

This trial is active, not recruiting.

Condition metastatic diffuse gastric cancer including carcinoma of the gastro-esophageal junction
Treatments s-1 (tegafur/gimeracil/oteracil) /cisplatin (investigational arm), fluorouracil/cisplatin (control arm)
Phase phase 3
Sponsor Taiho Oncology, Inc.
Start date February 2011
End date December 2016
Trial size 500 participants
Trial identifier NCT01285557, TPU-S1303

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 esophagogastric junction cancer previously untreated with chemotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
s-1 (tegafur/gimeracil/oteracil) /cisplatin (investigational arm) TS-1, Tegafur/Gimeracil/Oteracil
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.
(Active Comparator)
fluorouracil/cisplatin (control arm) TS-1, Tegafur/Gimeracil/Oteracil
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.

Primary Outcomes

Measure
Outcome Measure: Overall survival (OS)
time frame: 12 months after the last patient is randomized or the target number of events is reached, whichever is later

Secondary Outcomes

Measure
Progression-free survival (PFS)
time frame: Throughout
Time to treatment failure (TTF)
time frame: Throughout
Antitumor activity: Overall Response Rate (ORR), duration of response (DR), time to tumor response (TTR);
time frame: Throughout
Safety and tolerability
time frame: Treatment period

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Has given written Informed Consent - Histologically confirmed, unresectable, metastatic diffuse gastric cancer including carcinoma of the gastro-esophageal junction - No prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant chemotherapy more than 12 months ago - Life expectancy of at least 3 months - Able to take medications orally - ECOG performance status 0 to 1 - Adequate organ function (bone marrow, kidney and liver) Exclusion Criteria: - Certain type(s) of non-measurable lesion(s), if the only one(s). - Certain serious illness or medical condition(s) - Lost greater than or equal to 10% of body weight in the 3 months proceeding signing the ICF - Treatment with drugs interacting with S-1, 5-FU, or cisplatin. - Pregnant or lactating female. - Known hypersensitivity to fluoropyrimidines or cisplatin. Other protocol-defined inclusion/exclusion criteria may apply

Additional Information

Official title An Open-Label, Multicenter, Randomized, Phase 3 Study of S-1 and Cisplatin Compared With 5-FU and Cisplatin in Patients With Metastatic Diffuse Gastric Cancer Previously Untreated With Chemotherapy
Principal investigator Jaffer Ajani, MD
Description This is an open-label, international, Phase 3 study evaluating the efficacy and safety of the S-1/cisplatin regimen versus the 5-FU/cisplatin regimen in chemotherapy-naïve patients with metastatic diffuse gastric carcinoma including carcinoma of the gastro-esophageal junction. Patients will be randomly assigned to S-1/cisplatin (experimental regimen, Arm A) or 5-FU/cisplatin (control regimen, Arm B).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Taiho Oncology, Inc..