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.

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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).

View Eligibility Criteria

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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

361

Study ID:

NCT01285557

Recruitment Status:

Terminated

Sponsor:

Taiho Oncology, Inc.

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There are 85 Locations for this study

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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

Ijuí , 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

Nyíregyháza , 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

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

361

Study ID:

NCT01285557

Recruitment Status:

Terminated

Sponsor:


Taiho Oncology, Inc.

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