Trial · NCT00278863
Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial
NCT00278863, Phase 2, Completed, Asan Medical Center; results first posted 2014-02-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial. Trials, record NCT00278863. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00278863
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial
- NCT number
- NCT00278863
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 96 participants, actual
- Lead sponsor
- Asan Medical Center
- Conditions
- Gastric Cancer
- Interventions
- S-1, Capecitabine
- First posted
- 2006-01-19
- Last updated
- 2014-02-25
- Results first posted
- 2014-02-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate | Up to 2 years | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), \>20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD Response rate is defined as the proportion of patients who showed OR. |
| Secondary | Number of Patients With Adverse Events | Up to 2 years | Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate | Up to 2 years | percentage of participants | NUMBER | |
| SECONDARY | Number of Patients With Adverse Events | Up to 2 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate | S-1 for 2 Week on/1 Week Off | 28.9 | 95% Confidence Interval 15.6 to 42.1 | percentage of participants | |
| Response Rate | Capecitabine 2 Weeks on/1 Week Off | 26.1 | 95% Confidence Interval 13.4 to 38.8 | percentage of participants | |
| Number of Patients With Adverse Events | S-1 for 2 Week on/1 Week Off | 42 | participants | ||
| Number of Patients With Adverse Events | Capecitabine 2 Weeks on/1 Week Off | 44 | participants |
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 for 2 Week on/1 Week Off | 49 | |
| Overall Study | STARTED | Capecitabine 2 Weeks on/1 Week Off | 47 | |
| Overall Study | COMPLETED | S-1 for 2 Week on/1 Week Off | 44 | |
| Overall Study | COMPLETED | Capecitabine 2 Weeks on/1 Week Off | 45 | |
| Overall Study | NOT COMPLETED | S-1 for 2 Week on/1 Week Off | 5 | |
| Overall Study | NOT COMPLETED | Capecitabine 2 Weeks on/1 Week Off | 2 |
Source ClinicalTrials.gov
Adverse events26
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 | Anemia | Blood and lymphatic system disorders | S-1 for 2 Week on/1 Week Off | 37 | 42 | |
| other | Anemia | Blood and lymphatic system disorders | Capecitabine 2 Weeks on/1 Week Off | 39 | 44 | |
| other | Leukopenia | Blood and lymphatic system disorders | S-1 for 2 Week on/1 Week Off | 14 | 42 | |
| other | Leukopenia | Blood and lymphatic system disorders | Capecitabine 2 Weeks on/1 Week Off | 10 | 44 | |
| other | Neutropenia | Blood and lymphatic system disorders | S-1 for 2 Week on/1 Week Off | 10 | 42 | |
| other | Neutropenia | Blood and lymphatic system disorders | Capecitabine 2 Weeks on/1 Week Off | 13 | 44 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | S-1 for 2 Week on/1 Week Off | 12 | 42 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Capecitabine 2 Weeks on/1 Week Off | 12 | 44 | |
| other | Asthenia | General disorders | S-1 for 2 Week on/1 Week Off | 34 | 42 | |
| other | Asthenia | General disorders | Capecitabine 2 Weeks on/1 Week Off | 34 | 44 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | S-1 for 2 Week on/1 Week Off | ||
| Total, all-cause mortality | Capecitabine 2 Weeks on/1 Week Off | ||
| Total, other adverse events | S-1 for 2 Week on/1 Week Off | 42 | 42 |
| Total, other adverse events | Capecitabine 2 Weeks on/1 Week Off | 44 | 44 |
| Total, serious adverse events | S-1 for 2 Week on/1 Week Off | 0 | 42 |
| Total, serious adverse events | Capecitabine 2 Weeks on/1 Week Off | 0 | 44 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| S-1 for 2 Week on/1 Week Off vs Capecitabine 2 Weeks on/1 Week Off: Number of Patients With Adverse Events | Trial comparisons |
| S-1 for 2 Week on/1 Week Off vs Capecitabine 2 Weeks on/1 Week Off: serious adverse events | 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/NCT00278863
GET https://conductscience.org/api/trials/v1/NCT00278863/events?page=2