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Spots Global Cancer Trial Database for A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer

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Trial Identification

Brief Title: A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer

Official Title: An Open-label, Multi-center Study to Evaluate the Disease Free Survival Rate of a Perioperative Combination of Capecitabine (Xeloda), Trastuzumab (Herceptin) and Oxaliplatin (XELOX- Trastuzumab) in Patients With Resectable Gastric or Gastro-esophageal Junction Adenocarcinoma

Study ID: NCT01130337

Conditions

Gastric Cancer

Study Description

Brief Summary: This study will evaluate the disease free survival rate of a combination of capecitabine \[Xeloda\] and oxaliplatin (XELOX) with trastuzumab \[Herceptin\] in patients with resectable gastric cancer. The combination of Xeloda (orally, 1000 mg/m2 on day 1-14 of every cycle) and Herceptin (intravenously, 8 mg/kg loading dose, then 6 mg/kg on days 1-14 of every cycle) will be administered for three cycles prior to surgery to resect the tumor. If complete resection, R0 or microscopic residual tumor R1 is achieved, patients will continue with three cycles of XELOX and Herceptin and then for completion of 12 months treatment with Herceptin alone. Oxaliplatin will be administered intravenously at a dose of 130 mg/m2 on day 1 in every cycle. The anticipated time on study drug will be 12 months.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

, Elche, Alicante, Spain

, Oviedo, Asturias, Spain

, Santander, Cantabria, Spain

, San Sebastian, Guipuzcoa, Spain

, Palma de Mallorca, Islas Baleares, Spain

, Vigo, Pontevedra, Spain

, La Laguna, Tenerife, Spain

, Barakaldo, Vizcaya, Spain

, Barcelona, , Spain

, Barcelona, , Spain

, Barcelona, , Spain

, Barcelona, , Spain

, Barcelona, , Spain

, Burgos, , Spain

, Cordoba, , Spain

, Granada, , Spain

, La Coruña, , Spain

, Leon, , Spain

, Lerida, , Spain

, Lugo, , Spain

, Madrid, , Spain

, Madrid, , Spain

, Madrid, , Spain

, Orense, , Spain

, Sevilla, , Spain

, Sevilla, , Spain

, Toledo, , Spain

, Valencia, , Spain

, Valencia, , Spain

, Zaragoza, , Spain

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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