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

December 29, 2009
October 17, 2013
September 2005
June 2010   (final data collection date for primary outcome measure)
Overall survival\n [ Time Frame: Through study completion ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Throughout study, 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01041404 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • 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
  • Experimental: 1
    Interventions:
    • Drug: trastuzumab [Herceptin]
    • Drug: fluorouracil
    • Drug: cisplatin
    • Drug: capecitabine
  • Active Comparator: 2
    Interventions:
    • Drug: fluorouracil
    • Drug: cisplatin
    • Drug: capecitabine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
594
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Brazil,   China,   Costa Rica,   Denmark,   Finland,   France,   Germany,   Guatemala,   India,   Italy,   Japan,   Korea, Republic of,   Mexico,   Panama,   Peru,   Portugal,   Russian Federation,   South Africa,   Spain,   Taiwan,   Turkey,   United Kingdom
 
NCT01041404
BO18255
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Chugai Pharmaceutical
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2013

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