Trial · NCT00454636
A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.
NCT00454636, Phase 2, Completed, Hoffmann-La Roche; results first posted 2016-08-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer. Trials, record NCT00454636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00454636
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.
- NCT number
- NCT00454636
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 158 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Gastric Cancer
- Interventions
- Cisplatin, Capecitabine, Epirubicin, Cisplatin, Capecitabine, Oxaliplatin, Docetaxel, Capecitabine
- First posted
- 2007-04-02
- Last updated
- 2016-09-29
- Results first posted
- 2016-08-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) | Approximately 3.25 years | |
| Secondary | Overall Response Rate (ORR) | Approximately 3.25 years | ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. |
| Secondary | Progression-Free Survival (PFS) | Approximately 3.25 years | PFS was defined as the time from the start of treatment to the first documentation of disease progression or death for any cause. Disease progression was based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria and was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Secondary | Overall Survival (OS) | Approximately 3.25 years | OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up. |
| Secondary | Duration of Response | Approximately 3.25 years | Duration of Response was defined as the time of complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease, based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. Progressive disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Secondary | Time to Response | Approximately 3.25 years | Time to Response was defined as the date of start of treatment until the first date of complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) | Approximately 3.25 years | Safety population: All participants who received at least one dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | Approximately 3.25 years | Intent-to-Treat (ITT) population: included all participants who received at least one dose of study medication and had baseline and at least one subsequent tumor assessment. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | Approximately 3.25 years | Safety population: All participants who received at least one dose of study medication. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Approximately 3.25 years | Safety population: All participants who received at least one dose of study medication. | months | MEDIAN |
| SECONDARY | Duration of Response | Approximately 3.25 years | Safety population: All participants who received at least one dose of study medication. Only participants who reported either a complete response or a partial response were assessed. | days | MEAN |
| SECONDARY | Time to Response | Approximately 3.25 years | Safety population: All participants who received at least one dose of study medication. Only participants who reported either a complete response or a partial response were assessed. | days | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) | Cisplatin / Capecitabine | 2.4 | percentage of participants | ||
| Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) | Epirubicin / Cisplatin / Capecitabine | 6.3 | percentage of participants | ||
| Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) | Epirubicin / Oxaliplatin / Capecitabine | 3.7 | percentage of participants | ||
| Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) | Docetaxel / Cisplatin / Capecitabine | 5.2 | percentage of participants | ||
| Overall Response Rate (ORR) | Cisplatin / Capecitabine | 43.3 | 95% Confidence Interval 25.5 to 62.6 | percentage of participants | |
| Overall Response Rate (ORR) | Epirubicin / Cisplatin / Capecitabine | 40.7 | 95% Confidence Interval 22.4 to 61.2 | percentage of participants | |
| Overall Response Rate (ORR) | Epirubicin / Oxaliplatin / Capecitabine | 69.6 | 95% Confidence Interval 47.1 to 86.8 | percentage of participants | |
| Overall Response Rate (ORR) | Docetaxel / Cisplatin / Capecitabine | 59.6 | 95% Confidence Interval 45.1 to 73.0 | percentage of participants | |
| Progression-Free Survival (PFS) | Cisplatin / Capecitabine | 4.43 | 95% Confidence Interval 3.10 to 7.70 | months | |
| Progression-Free Survival (PFS) | Epirubicin / Cisplatin / Capecitabine | 5.17 | 95% Confidence Interval 2.97 to 6.23 | months |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cisplatin / Capecitabine | 41 | |
| Overall Study | STARTED | Epirubicin / Cisplatin / Capecitabine | 32 | |
| Overall Study | STARTED | Epirubicin / Oxaliplatin / Capecitabine | 27 | |
| Overall Study | STARTED | Docetaxel / Cisplatin / Capecitabine | 58 | |
| Overall Study | COMPLETED | Cisplatin / Capecitabine | 10 | |
| Overall Study | COMPLETED | Epirubicin / Cisplatin / Capecitabine | 9 | |
| Overall Study | COMPLETED | Epirubicin / Oxaliplatin / Capecitabine | 7 | |
| Overall Study | COMPLETED | Docetaxel / Cisplatin / Capecitabine | 26 | |
| Overall Study | NOT COMPLETED | Cisplatin / Capecitabine | 31 | |
| Overall Study | NOT COMPLETED | Epirubicin / Cisplatin / Capecitabine | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events380
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 | Cisplatin / Capecitabine | 10 | 41 | |
| other | Anaemia | Blood and lymphatic system disorders | Epirubicin / Cisplatin / Capecitabine | 12 | 32 | |
| other | Anaemia | Blood and lymphatic system disorders | Epirubicin / Oxaliplatin / Capecitabine | 7 | 27 | |
| other | Anaemia | Blood and lymphatic system disorders | Docetaxel / Cisplatin / Capecitabine | 19 | 58 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cisplatin / Capecitabine | 0 | 41 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Epirubicin / Cisplatin / Capecitabine | 1 | 32 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Epirubicin / Oxaliplatin / Capecitabine | 2 | 27 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Docetaxel / Cisplatin / Capecitabine | 2 | 58 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cisplatin / Capecitabine | 1 | 41 | |
| other | Leukopenia | Blood and lymphatic system disorders | Epirubicin / Cisplatin / Capecitabine | 2 | 32 |
1 to 10 of 380Source ClinicalTrials.gov
See all 380 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cisplatin / Capecitabine | ||
| Total, all-cause mortality | Epirubicin / Cisplatin / Capecitabine | ||
| Total, all-cause mortality | Epirubicin / Oxaliplatin / Capecitabine | ||
| Total, all-cause mortality | Docetaxel / Cisplatin / Capecitabine | ||
| Total, other adverse events | Cisplatin / Capecitabine | 39 | 41 |
| Total, other adverse events | Epirubicin / Cisplatin / Capecitabine | 30 | 32 |
| Total, other adverse events | Epirubicin / Oxaliplatin / Capecitabine | 27 | 27 |
| Total, other adverse events | Docetaxel / Cisplatin / Capecitabine | 54 | 58 |
| Total, serious adverse events | Cisplatin / Capecitabine | 9 | 41 |
| Total, serious adverse events | Epirubicin / Cisplatin / Capecitabine | 12 | 32 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00454636
GET https://conductscience.org/api/trials/v1/NCT00454636/results?page=2