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 31, 2014
Last verified: October 2014
Results First Received: July 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastric Cancer
Interventions: Drug: Trastuzumab
Drug: Fluorouracil
Drug: Cisplatin
Drug: Capecitabine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Fluoropyrimidine/Cisplatin (FP) Participants received fluoropyrimidine (EITHER 5-fluorouracil [5-FU] or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 milligrams per square meter (mg/m^2), intravenously (IV), on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, orally (PO), twice daily (BID) from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 milligrams per kilogram (mg/kg), IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.

Participant Flow:   Overall Study
    Fluoropyrimidine/Cisplatin (FP)     Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)  
STARTED     290     294  
Entered Follow-Up     251     251  
Died in Follow-up     199     200  
Lost to Follow-up     12     10  
Alive in Follow-up     40     41  
COMPLETED     0 [1]   0 [1]
NOT COMPLETED     290     294  
Adverse Event                 45                 35  
Lack of Efficacy                 200                 210  
Violation of Selection Criteria                 0                 1  
Protocol Violation                 4                 0  
Withdrawal by Subject                 29                 23  
Failure to Return                 1                 2  
Not Specified                 11                 23  
[1] Summary of withdrawals represents withdrawals from treatment, rather than withdrawals from study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment.

Reporting Groups
  Description
Fluoropyrimidine/Cisplatin (FP) Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
Total Total of all reporting groups

Baseline Measures
    Fluoropyrimidine/Cisplatin (FP)     Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)     Total  
Number of Participants  
[units: participants]
  290     294     584  
Age  
[units: years]
Mean (Standard Deviation)
  58.5  (11.22)     59.4  (10.75)     59.0  (10.99)  
Gender  
[units: participants]
     
Female     72     68     140  
Male     218     226     444  



  Outcome Measures
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1.  Primary:   Overall Survival (OS) - Percentage of Participants With an Event   [ Time Frame: Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]

2.  Primary:   Overall Survival - Time to Event   [ Time Frame: BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]

3.  Secondary:   Progression-Free Survival (PFS) - Percentage of Participants With an Event   [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]

4.  Secondary:   Progression-Free Survival - Time to Event   [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]

5.  Secondary:   Time to Progression (TTP) - Percentage of Participants With an Event   [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]

6.  Secondary:   Time to Progression - Time to Event   [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]

7.  Secondary:   Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]

8.  Secondary:   Duration of Response - Percentage of Participants With an Event   [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]

9.  Secondary:   Duration of Response   [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]

10.  Secondary:   Percentage of Participants With Clinical Benefit   [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]

11.  Secondary:   European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores   [ Time Frame: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]

12.  Secondary:   EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores   [ Time Frame: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]

13.  Secondary:   Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)   [ Time Frame: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]

14.  Secondary:   Percentage of Participants With a Change in Analgesic Medication During the Study   [ Time Frame: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]

15.  Secondary:   Body Weight (Kilograms [kg]) at BL   [ Time Frame: BL ]

16.  Secondary:   Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight   [ Time Frame: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]

17.  Secondary:   Steady State Trastuzumab Area Under the Concentration (AUC)   [ Time Frame: Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106 ]

18.  Secondary:   Trastuzumab Minimum Serum Concentration (Cmin)   [ Time Frame: Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106 ]

19.  Secondary:   Trastuzumab Maximum Serum Concentration (Cmax)   [ Time Frame: Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01041404     History of Changes
Other Study ID Numbers: BO18255
Study First Received: December 29, 2009
Results First Received: July 22, 2014
Last Updated: October 31, 2014
Health Authority: Australia: National Health and Medical Research Council