Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: May 25, 2010
Last updated: February 5, 2015
Last verified: February 2015

May 25, 2010
February 5, 2015
July 2010
June 2014   (final data collection date for primary outcome measure)
Disease free survival defined as 18 months disease free survival rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01130337 on Archive Site
  • Pathological response according to Mandard criteria [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • R0 tumor resection rate [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
  • Objective reponse rates according to RECIST criteria [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]
  • Toxicity of treatment [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer
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

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.

Not Provided
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • Drug: Capecitabine [Xeloda]
    1.000 mg/m2 orally every 12 hours from day 1 to day 14 of every cycle for 6 cycles
  • Drug: Oxalipatin
    130 mg/m2 intravenous infusion day 1 of every cycle
  • Drug: Trastuzumab [Herceptin]
    First dose 8 mg/kg, subsequent cycles 6 mg/kg, intravenously, day of every cycle for 15 cycles
Experimental: 1
  • Drug: Capecitabine [Xeloda]
  • Drug: Oxalipatin
  • Drug: Trastuzumab [Herceptin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2014
June 2014   (final data collection date for primary outcome measure)

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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP