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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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, 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
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR