Phase 3
N=584
ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer
Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01041404 ↗Enrolled (actual)
584
Serious AEs
32.0%
Results posted
Nov 2014
Primary outcome: Primary: Overall Survival (OS) - Percentage of Participants With an Event — 62.8; 56.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Trastuzumab (Drug); Fluorouracil (Drug); Cisplatin (Drug); Capecitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) - Percentage of Participants With an Event |
62.8; 56.8 | — |
| PRIMARY Overall Survival - Time to Event |
11.1; 13.8 | 0.0046 sig |
| SECONDARY Progression-Free Survival (PFS) - Percentage of Participants With an Event |
81.0; 76.9 | — |
| SECONDARY Progression-Free Survival - Time to Event |
5.5; 6.7 | 0.0002 sig |
| SECONDARY Time to Progression (TTP) - Percentage of Participants With an Event |
74.1; 70.7 | — |
| SECONDARY Time to Progression - Time to Event |
5.6; 7.1 | 0.0003 sig |
| SECONDARY Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST) |
34.5; 47.3 | 0.0017 sig |
| SECONDARY Duration of Response - Percentage of Participants With an Event |
80.0; 71.9 | — |
| SECONDARY Duration of Response |
4.8; 6.9 | <0.0001 sig |
| SECONDARY Percentage of Participants With Clinical Benefit |
69.3; 78.9 | 0.0081 sig |
| SECONDARY European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores |
55.3; 54.9; 61.0; 60.9; 60.9; 60.5 | — |
| SECONDARY EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores |
18.7; 16.6; 11.8; 12.5; 10.9; 12.8 | — |
| SECONDARY Pain Intensity Scores as Assessed By Visual Analog Scale (VAS) |
21.1; 17.9; 14.6; 13.3; 11.1; 13.8 | — |
| SECONDARY Percentage of Participants With a Change in Analgesic Medication During the Study |
29.0; 29.3; 5.9; 1.7; 0.3; 0.3 | — |
| SECONDARY Body Weight (Kilograms [kg]) at BL |
60; 61 | — |
| SECONDARY Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight |
1.5; 1.1; 51.6; 50.5; 28.2; 27.2 | — |
| SECONDARY Steady State Trastuzumab Area Under the Concentration (AUC) |
1030 | — |
| SECONDARY Trastuzumab Minimum Serum Concentration (Cmin) |
23.0 | — |
| SECONDARY Trastuzumab Maximum Serum Concentration (Cmax) |
128 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01041404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.