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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction

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Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Outcome Measure: Overall survival (OS)

Outcome Time Frame:

12 months after the last patient is randomized or the target number of events is reached, whichever is later

Safety Issue:

No

Principal Investigator

Jaffer Ajani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

TPU-S1303

NCT ID:

NCT01285557

Start Date:

February 2011

Completion Date:

August 2014

Related Keywords:

  • Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction
  • Gastric Cancer , S-1, Phase 3
  • Carcinoma
  • Esophageal Diseases
  • Stomach Neoplasms

Name

Location
Fountain Valley, California  92708
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Albuquerque, New Mexico  87131-5636
Metairie, Louisiana  70006
Charleston, South Carolina