Trial · NCT00400179
A Safety and Efficacy Study in Patients With Gastric Cancer
NCT00400179, Phase 3, Completed, Taiho Oncology, Inc.; results first posted 2012-04-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Efficacy Study in Patients With Gastric Cancer. Trials, record NCT00400179. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00400179
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study in Patients With Gastric Cancer
- NCT number
- NCT00400179
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,053 participants, actual
- Lead sponsor
- Taiho Oncology, Inc.
- Conditions
- Gastric Cancer
- Interventions
- S-1/Cisplatin, 5-FU/cisplatin
- First posted
- 2006-11-16
- Last updated
- 2024-09-19
- Results first posted
- 2012-04-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Survival | The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized). | Survival was defined as the time from the date of randomization to the time of death (from any cause) for each patient. |
| Secondary | Overall Response Rate (ORR) | Data cutoff was 07 March 2008 (12 months after last patient randomized). | The proportion of patients with objective evidence of complete response (CR) or partial response (PR) based on tumor response assessments. Per the Response Evaluation Criteria in Solid tumors (RECIST), CR was defined as the disappearance of all target lesions for at least 4 weeks, and PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions. |
| Secondary | Duration of Response (DR) | Data cutoff was 07 March 2008 (12 months after last patient was randomized). | Duration of response was defined as the time from date of first confirmed response (CR or PR) to date of first progressive disease (PD) or death. Per the RECIST criteria, definitions were as follows: CR was the disappearance of all target lesions for at least 4 weeks, PR was at least a 30% decrease in the sum of the longest diameter of target lesions, and PD was at least a 20% increase in the sum of the longest diameter of target lesions. |
| Secondary | Progression-free Survival (PFS) | From date of randomization until date of first documented PD, date of death, or until data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first. | The time from randomization to date of first documented PD or date of death, whichever occurred first. |
| Secondary | Time to Treatment Failure (TTF) | From date of randomization until date of permanent discontinuation of S-1 or 5-FU, first documented PD, death, or data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first. | The time from randomization to date of permanent discontinuation of S-1 or 5-FU, first documented PD, or death, whichever occurred first. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Overall Response Rate (ORR) | Data cutoff was 07 March 2008 (12 months after last patient randomized). | Percentage of patients in each group | NUMBER | |
| SECONDARY | Duration of Response (DR) | Data cutoff was 07 March 2008 (12 months after last patient was randomized). | Months | MEDIAN | |
| SECONDARY | Progression-free Survival (PFS) | From date of randomization until date of first documented PD, date of death, or until data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first. | Months | MEDIAN | |
| SECONDARY | Time to Treatment Failure (TTF) | From date of randomization until date of permanent discontinuation of S-1 or 5-FU, first documented PD, death, or data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first. | Months | MEDIAN | |
| PRIMARY | Median Survival | The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized). | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | S-1/Cisplatin | 29.1 | 95% Confidence Interval 24.7 to 33.8 | Percentage of patients in each group | |
| Overall Response Rate (ORR) | 5-FU/Cisplatin | 31.9 | 95% Confidence Interval 27.3 to 36.9 | Percentage of patients in each group | |
| Duration of Response (DR) | S-1/Cisplatin | 6.5 | 95% Confidence Interval 5.8 to 7.4 | Months | |
| Duration of Response (DR) | 5-FU/Cisplatin | 5.8 | 95% Confidence Interval 5.5 to 6.1 | Months | |
| Progression-free Survival (PFS) | S-1/Cisplatin | 4.8 | 95% Confidence Interval 4.0 to 5.5 | Months | |
| Progression-free Survival (PFS) | 5-FU/Cisplatin | 5.5 | 95% Confidence Interval 4.4 to 5.8 | Months | |
| Time to Treatment Failure (TTF) | S-1/Cisplatin | 3.8 | 95% Confidence Interval 3.7 to 4.0 | Months | |
| Time to Treatment Failure (TTF) | 5-FU/Cisplatin | 3.8 | 95% Confidence Interval 3.7 to 4.4 | Months | |
| Median Survival | S-1/Cisplatin | 8.6 | 95% Confidence Interval 7.9 to 9.5 | Months | |
| Median Survival | 5-FU/Cisplatin | 7.9 | 95% Confidence Interval 7.2 to 8.5 | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | S-1/Cisplatin | 527 | |
| Overall Study | STARTED | 5-FU/Cisplatin | 526 | |
| Overall Study | COMPLETED | S-1/Cisplatin | 521 | |
| Overall Study | COMPLETED | 5-FU/Cisplatin | 508 | |
| Overall Study | NOT COMPLETED | S-1/Cisplatin | 6 | |
| Overall Study | NOT COMPLETED | 5-FU/Cisplatin | 18 |
Source ClinicalTrials.gov
Adverse events694
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 | Anaemia | Blood and lymphatic system disorders | S-1/Cisplatin | 229 | 521 | 404 |
| other | Anaemia | Blood and lymphatic system disorders | 5-FU/Cisplatin | 234 | 508 | 380 |
| other | Neutropenia | Blood and lymphatic system disorders | S-1/Cisplatin | 149 | 521 | 383 |
| other | Neutropenia | Blood and lymphatic system disorders | 5-FU/Cisplatin | 240 | 508 | 588 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | S-1/Cisplatin | 92 | 521 | 174 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | 5-FU/Cisplatin | 116 | 508 | 190 |
| other | Leukopenia | Blood and lymphatic system disorders | S-1/Cisplatin | 91 | 521 | 224 |
| other | Leukopenia | Blood and lymphatic system disorders | 5-FU/Cisplatin | 117 | 508 | 254 |
| other | Lymphopenia | Blood and lymphatic system disorders | S-1/Cisplatin | 26 | 521 | 54 |
| other | Lymphopenia | Blood and lymphatic system disorders | 5-FU/Cisplatin | 34 | 508 | 126 |
1 to 10 of 694Source ClinicalTrials.gov
See all 694 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | S-1/Cisplatin | ||
| Total, all-cause mortality | 5-FU/Cisplatin | ||
| Total, other adverse events | S-1/Cisplatin | 514 | 521 |
| Total, other adverse events | 5-FU/Cisplatin | 504 | 508 |
| Total, serious adverse events | S-1/Cisplatin | 257 | 521 |
| Total, serious adverse events | 5-FU/Cisplatin | 248 | 508 |
Source ClinicalTrials.gov
Papers2
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 |
|---|
| S-1/Cisplatin vs 5-FU/Cisplatin: 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/NCT00400179
GET https://conductscience.org/api/trials/v1/NCT00400179/events?page=2