Esophageal Cancer Clinical Trial
Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial
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.
Full 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).
Eligibility Criteria
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.
Eastern Cooperative Oncology Group 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 Informed Consent Form.
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.
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There are 85 Locations for this study
Alexandria Louisiana, 71301, United States
Albuquerque New Mexico, 87131, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Rosario Santa Fe, S2000, Argentina
Ciudad Autonoma de Buenos Aires , 1264, Argentina
Bruxelles , 1200, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Salvador BA, 41820, Brazil
Porto Alegre RS, 90610, Brazil
Barretos SP, 14784, Brazil
Ribeirão Preto SP, 14015, Brazil
São Paulo SP, 01246, Brazil
São Paulo SP, 01406, Brazil
Belo Horizonte , 31110, Brazil
Fortaleza , 60160, Brazil
Ijuà , 98700, Brazil
Porto Alegre , 90050, Brazil
Pleven , 5800, Bulgaria
Vratsa , 3000, Bulgaria
Osijek , 31000, Croatia
Zagreb , 10000, Croatia
Tallinn , 11312, Estonia
Tallinn , 13419, Estonia
Essen , 45147, Germany
Budapest , 1032, Hungary
Budapest , 1122, Hungary
Győor , 9024, Hungary
NyÃregyháza , 4400, Hungary
Pécs , 7624, Hungary
Szeged , 6720, Hungary
Székesfehérvár , 8000, Hungary
Tel Aviv , 64239, Israel
Ancona , 60020, Italy
Candiolo , 10060, Italy
Milano , 20141, Italy
Modena , 41100, Italy
Potenza , 85100, Italy
Reggio Emilia , 42100, Italy
Rimini , 47900, Italy
Chihuahua , 31000, Mexico
Mexico City , 14080, Mexico
Oaxaca , 68000, Mexico
Szczecin , 71-73, Poland
Warszawa , 02-78, Poland
Aveiro , 3814-, Portugal
Coimbra , 3000-, Portugal
Lisboa , 1649-, Portugal
Porto , 4200-, Portugal
Baia Mare , 43003, Romania
Cluj-Napoca , 40001, Romania
Craiova , 20038, Romania
Iasi , 70010, Romania
Barnaul , 65604, Russian Federation
Krasnodar , 35004, Russian Federation
Moscow , 11547, Russian Federation
Pyatigorsk , 35750, Russian Federation
Saint Petersburg , 19702, Russian Federation
Saint Petersburg , 19775, Russian Federation
Saint-Petersburg , 19421, Russian Federation
Groenkloof Pretoria Gauteng, 0181, South Africa
Pretoria Gauteng, 0002, South Africa
Durban KZN, 4091, South Africa
Cape Town Western Cape, 7500, South Africa
Sabadell Barcelona, 08208, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08907, Spain
Madrid , 28007, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Cherkassy , 18009, Ukraine
Chernivtsiy , 58013, Ukraine
Dnepropetrovsk , 49102, Ukraine
Donetsk , 83092, Ukraine
Kharkiv , 61070, Ukraine
Kyiv , 3115, Ukraine
Lutsk , 43018, Ukraine
Lviv , 79031, Ukraine
Sumy , 40005, Ukraine
Uzhgorod , 88000, Ukraine
Zaporizzhya , 69040, Ukraine
Rhyl Wales, LL18 , United Kingdom
London , W12 0, United Kingdom
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