ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer

This study has been completed.
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01041404
First received: December 29, 2009
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg) every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800 mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab (Herceptin) will continue until disease progression. The target sample size is 300-600 patients.


Condition Intervention Phase
Gastric Cancer
Drug: trastuzumab [Herceptin]
Drug: fluorouracil
Drug: cisplatin
Drug: capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study of the Effect of First-line Herceptin in Combination With a Fluoropyrimidine and Cisplatin Versus Chemotherapy Alone on Overall Survival in Patients With HER2-positive Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival\n [ Time Frame: Through study completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival, time to progression [ Time Frame: Tumor assessments: every 6 weeks ] [ Designated as safety issue: No ]
  • Overall response rate, clinical benefit rate, duration of response [ Time Frame: Tumor assessments: every 6 weeks ] [ Designated as safety issue: No ]
  • Safety: AEs, laboratory parameters, vital signs, LVEF, creatinine clearance [ Time Frame: AEs: throughout study, laboratory parameters, vital signs, creatinine clearance: 1x every cycle, LVEF: every 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 594
Study Start Date: September 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: trastuzumab [Herceptin]
loading dose 8 mg/kg, 6 mg/kg intravenous infusion every 3 weeks
Other Name: Herceptin
Drug: fluorouracil
800 mg/m2/day intravenous infusion every 3 weeks for 6 cycles
Drug: cisplatin
80 mg/m2 intravenous infusion every 3 weeks for 6 cycles
Drug: capecitabine
1000 mg/m2 po twice daily for 14 days every 3 weeks for 6 cycles
Other Name: Xeloda
Active Comparator: 2 Drug: fluorouracil
800 mg/m2/day intravenous infusion every 3 weeks for 6 cycles
Drug: cisplatin
80 mg/m2 intravenous infusion every 3 weeks for 6 cycles
Drug: capecitabine
1000 mg/m2 po twice daily for 14 days every 3 weeks for 6 cycles
Other Name: Xeloda

  Eligibility

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

Inclusion Criteria:

  • Adult patients >=18 years of age
  • Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction
  • Adenocarcinoma
  • HER2-positive tumors

Exclusion Criteria:

  • Previous chemotherapy for advanced/metastatic disease
  • Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome
  • History of cardiac disease
  • Dyspnoea at rest, due to complications of advanced malignancy or other disease, or patients who require supportive oxygen therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041404

  Show 142 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Chugai Pharmaceutical
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01041404     History of Changes
Other Study ID Numbers: BO18255
Study First Received: December 29, 2009
Last Updated: October 17, 2013
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Trastuzumab
Capecitabine
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 16, 2014