Trial · NCT01041404
ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer
NCT01041404, Phase 3, Completed, Hoffmann-La Roche; results first posted 2014-11-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer. Trials, record NCT01041404. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01041404
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer
- NCT number
- NCT01041404
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 584 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Gastric Cancer
- Interventions
- Trastuzumab, Fluorouracil, Cisplatin, Capecitabine
- First posted
- 2009-12-31
- Last updated
- 2014-11-05
- Results first posted
- 2014-11-05
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) - Percentage of Participants With an Event | 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 | OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up. |
| Primary | Overall Survival - Time to Event | 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 | The median time, in months, from the date of randomization to the date of an OS event. Participants were censored at the last date tumor measurement, the last date in the study drug log, or the date of last follow-up. |
| Secondary | Progression-Free Survival (PFS) - Percentage of Participants With an Event | 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 | PFS was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up. |
| Secondary | Progression-Free Survival - Time to Event | 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 | The median time, in months, from the date of randomization to the date of a PFS event. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up. |
| Secondary | Time to Progression (TTP) - Percentage of Participants With an Event | 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 | TTP was defined as the time from the date of randomization and the date of the first occurrence of PD. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up. |
| Secondary | Time to Progression - Time to Event | 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 | The median time, in months, from the date of randomized to the date of a TTP event. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up. |
| Secondary | Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST) | 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 | For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. |
| Secondary | Duration of Response - Percentage of Participants With an Event | 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 | Duration of response was defined for responders as the time from the date on which the CR or PR was first recorded to the date on which PD is first noted. Participants were censored on the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up. |
| Secondary | Duration of Response | 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 | The median time, in months, of the duration of response. Participants were censored at the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up. |
| Secondary | Percentage of Participants With Clinical Benefit | 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 | Clinical benefit was defined as stable disease (SD), CR, or PR for 6 weeks or longer as determined by RECIST. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as a reference the smallest SLD recorded since treatment had started. For NTLs, SD was defined as a persistence of one or more NTLs and/or maintenance of tumor marker levels above the normal limits. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) - Percentage of Participants With an Event | 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 | FAS | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) - Percentage of Participants With an Event | 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 | FAS | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival - Time to Event | 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 | FAS | months | MEDIAN |
| SECONDARY | Time to Progression (TTP) - Percentage of Participants With an Event | 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 | FAS | percentage of participants | NUMBER |
| SECONDARY | Time to Progression - Time to Event | 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 | FAS | months | MEDIAN |
| SECONDARY | Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST) | 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 | FAS | percentage of participants | NUMBER |
| SECONDARY | Duration of Response - Percentage of Participants With an Event | 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 | FAS; only participants with a CR or PR were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | 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 | FAS; only participants with a CR or PR were included in the analysis. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Clinical Benefit | 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 | FAS | percentage of participants | NUMBER |
| PRIMARY | Overall Survival - Time to Event | 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 | FAS | months | MEDIAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group2,535
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) - Percentage of Participants With an Event | Fluoropyrimidine/Cisplatin (FP) | 62.8 | percentage of participants | ||
| Overall Survival (OS) - Percentage of Participants With an Event | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 56.8 | percentage of participants | ||
| Progression-Free Survival (PFS) - Percentage of Participants With an Event | Fluoropyrimidine/Cisplatin (FP) | 81.0 | percentage of participants | ||
| Progression-Free Survival (PFS) - Percentage of Participants With an Event | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 76.9 | percentage of participants | ||
| Progression-Free Survival - Time to Event | Fluoropyrimidine, Cisplatin | 5.5 | 95% Confidence Interval 5 to 6 | months | |
| Progression-Free Survival - Time to Event | Trastuzumab, Fluoropyrimidine, Cisplatin | 6.7 | 95% Confidence Interval 6 to 8 | months | |
| Time to Progression (TTP) - Percentage of Participants With an Event | Fluoropyrimidine/Cisplatin (FP) | 74.1 | percentage of participants | ||
| Time to Progression (TTP) - Percentage of Participants With an Event | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 70.7 | percentage of participants | ||
| Time to Progression - Time to Event | Fluoropyrimidine/Cisplatin (FP) | 5.6 | 95% Confidence Interval 5 to 6 | months | |
| Time to Progression - Time to Event | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 7.1 | 95% Confidence Interval 6 to 8 | months |
1 to 10 of 2,535Source ClinicalTrials.gov
See all 2,535 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fluoropyrimidine/Cisplatin (FP) | 290 | |
| Overall Study | STARTED | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 294 | |
| Overall Study | Entered Follow-Up | Fluoropyrimidine/Cisplatin (FP) | 251 | |
| Overall Study | Entered Follow-Up | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 251 | |
| Overall Study | Died in Follow-up | Fluoropyrimidine/Cisplatin (FP) | 199 | |
| Overall Study | Died in Follow-up | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 200 | |
| Overall Study | Lost to Follow-up | Fluoropyrimidine/Cisplatin (FP) | 12 | |
| Overall Study | Lost to Follow-up | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 10 | |
| Overall Study | Alive in Follow-up | Fluoropyrimidine/Cisplatin (FP) | 40 | |
| Overall Study | Alive in Follow-up | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 41 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events352
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Fluoropyrimidine/Cisplatin (FP) | 189 | 290 | |
| other | Nausea | Gastrointestinal disorders | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 200 | 294 | |
| other | Vomiting | Gastrointestinal disorders | Fluoropyrimidine/Cisplatin (FP) | 135 | 290 | |
| other | Vomiting | Gastrointestinal disorders | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 146 | 294 | |
| other | Diarrhoea | Gastrointestinal disorders | Fluoropyrimidine/Cisplatin (FP) | 82 | 290 | |
| other | Diarrhoea | Gastrointestinal disorders | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 102 | 294 | |
| other | Constipation | Gastrointestinal disorders | Fluoropyrimidine/Cisplatin (FP) | 95 | 290 | |
| other | Constipation | Gastrointestinal disorders | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 76 | 294 | |
| other | Stomatitis | Gastrointestinal disorders | Fluoropyrimidine/Cisplatin (FP) | 45 | 290 | |
| other | Stomatitis | Gastrointestinal disorders | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 73 | 294 |
1 to 10 of 352Source ClinicalTrials.gov
See all 352 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluoropyrimidine/Cisplatin (FP) | ||
| Total, all-cause mortality | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | ||
| Total, other adverse events | Fluoropyrimidine/Cisplatin (FP) | 279 | 290 |
| Total, other adverse events | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 286 | 294 |
| Total, serious adverse events | Fluoropyrimidine/Cisplatin (FP) | 81 | 290 |
| Total, serious adverse events | Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H) | 106 | 294 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Fluoropyrimidine/Cisplatin (FP) vs Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01041404
GET https://conductscience.org/api/trials/v1/NCT01041404/results?page=2