A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer
NCT ID: NCT01130337
Last Updated: 2015-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2010-07-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Capecitabine [Xeloda]
1.000 mg/m2 orally every 12 hours from day 1 to day 14 of every cycle for 6 cycles
Oxaliplatin
130 mg/m2 intravenous infusion day 1 of every cycle
Trastuzumab [Herceptin]
First dose 8 mg/kg, subsequent cycles 6 mg/kg, intravenously, day of every cycle for 15 cycles
Interventions
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Capecitabine [Xeloda]
1.000 mg/m2 orally every 12 hours from day 1 to day 14 of every cycle for 6 cycles
Oxaliplatin
130 mg/m2 intravenous infusion day 1 of every cycle
Trastuzumab [Herceptin]
First dose 8 mg/kg, subsequent cycles 6 mg/kg, intravenously, day of every cycle for 15 cycles
Eligibility Criteria
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Inclusion Criteria
* Locally advanced resectable HER2-positive gastric or esophagogastric junction adenocarcinoma (Sievert types I, II, III)
* Measurable (RECIST criteria) or assessable disease
* ECOG performance 0-2
* Life expectancy of 12 weeks or more
Exclusion Criteria
* Previous chemotherapy or radiotherapy for gastric neoplasm or some kind of previous surgical resection of the tumor (except diagnostic laparoscopy)
* Concomitant heart disease
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Madrid, Madrid, Spain
Ourense, Orense, Spain
Vigo, Pontevedra, Spain
Oviedo, Principality of Asturias, Spain
Seville, Sevilla, Spain
Seville, Sevilla, Spain
San Cristóbal de La Laguna, Tenerife, Spain
Toledo, Toledo, Spain
Elche, Alicante, Spain
Palma de Mallorca, Balearic Islands, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Burgos, Burgos, Spain
Santander, Cantabria, Spain
Córdoba, Cordoba, Spain
Granada, Granada, Spain
Donostia / San Sebastian, Guipuzcoa, Spain
A Coruña, La Coruña, Spain
León, Leon, Spain
Lleida, Lerida, Spain
Lugo, Lugo, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Barakaldo, Vizcaya, Spain
Zaragoza, Zaragoza, Spain
Countries
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References
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Rivera F, Izquierdo-Manuel M, Garcia-Alfonso P, Martinez de Castro E, Gallego J, Limon ML, Alsina M, Lopez L, Galan M, Falco E, Manzano JL, Gonzalez E, Munoz-Unceta N, Lopez C, Aranda E, Fernandez E, Jorge M, Jimenez-Fonseca P. Perioperative trastuzumab, capecitabine and oxaliplatin in patients with HER2-positive resectable gastric or gastro-oesophageal junction adenocarcinoma: NEOHX phase II trial. Eur J Cancer. 2021 Mar;145:158-167. doi: 10.1016/j.ejca.2020.12.005. Epub 2021 Jan 20.
Other Identifiers
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ML25189
Identifier Type: -
Identifier Source: org_study_id
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