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 Gasro-esophageal Junction Adenocarcinoma
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer
Both
Gastric Cancer
Trial Information
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 Gasro-esophageal Junction Adenocarcinoma
Inclusion Criteria:
- Adult patients over 18 years of age
- 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:
- Immeasurable lesion as the only evidence of disease
- Previous chemotherapy or radiotherapy for gastric neoplasm or some kind of previous
surgical resection of the tumor (except diagnostic laparoscopy)
- Concomitant heart disease
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease free survival defined as 18 months disease free survival rate
Outcome Time Frame:
18 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Spain: Agencia Española del Medicamento y Productos Sanitarios
Study ID:
ML25189
NCT ID:
NCT01130337
Start Date:
July 2010
Completion Date:
March 2014
Related Keywords:
- Gastric Cancer
- Stomach Neoplasms
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