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
ClinicalTrials.gov Identifier:
First received: May 25, 2010
Last updated: September 1, 2015
Last verified: September 2015
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.

Condition Intervention Phase
Gastric Cancer
Drug: Capecitabine [Xeloda]
Drug: Oxaliplatin
Drug: Trastuzumab [Herceptin]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Disease-free Survival (DFS) at Month 18 [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    DFS was the time elapsed from the time of surgery (for complete resection [R0] participants) until the date on which progression or death from any cause was documented (whichever occured first). Progression was defined as target lesions greater than (>) 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 millimeter (mm) increase over the nadir. When the sum becomes very small, increases within the measurement error (2-3 mm) can lead to a 20% increase. Participants who did not present progression and who had not died were censored on the last date on which it was known that there was no progression (last response assessment).

Secondary Outcome Measures:
  • Percentage of Participants With Pathological Complete Response (pCR) [ Time Frame: Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25 ] [ Designated as safety issue: No ]
    pCR was defined as an absence of any invasive cancer cell of the primary tumor after the time of major neoadjuvant chemotherapy, with or without surgery.

  • Percentage of Participants With Complete Tumor Resection (R0) [ Time Frame: Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25 ] [ Designated as safety issue: No ]
    R0 resection was defined as having performed a complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation.

  • Percentage of Participants With Objective Response [ Time Frame: Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25 ] [ Designated as safety issue: No ]
    An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR was defined as the disappearance of all target lesions and persistence of greater than or equal to (≥) 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.

Enrollment: 36
Study Start Date: July 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Capecitabine [Xeloda]
1.000 mg/m2 orally every 12 hours from day 1 to day 14 of every cycle for 6 cycles
Drug: Oxaliplatin
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130337

Elche, Alicante, Spain, 03203
Oviedo, Asturias, Spain, 33006
Santander, Cantabria, Spain, 39008
San Sebastian, Guipuzcoa, Spain, 20014
Palma de Mallorca, Islas Baleares, Spain, 07198
Vigo, Pontevedra, Spain, 36204
La Laguna, Tenerife, Spain, 38320
Barakaldo, Vizcaya, Spain, 48903
Barcelona, Spain, 08003
Barcelona, Spain, 08035
Barcelona, Spain, 08916
Barcelona, Spain, 08907
Barcelona, Spain, 08036
Burgos, Spain, 09006
Cordoba, Spain, 14004
Granada, Spain, 18014
La Coruña, Spain, 15006
Leon, Spain, 24071
Lerida, Spain, 25198
Lugo, Spain, 27003
Madrid, Spain, 28007
Madrid, Spain, 28040
Madrid, Spain, 28041
Orense, Spain, 32005
Sevilla, Spain, 41014
Sevilla, Spain, 41013
Toledo, Spain, 45004
Valencia, Spain, 46009
Valencia, Spain, 46014
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01130337     History of Changes
Other Study ID Numbers: ML25189
Study First Received: May 25, 2010
Results First Received: September 1, 2015
Last Updated: September 1, 2015
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Site
Stomach Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2015