Trial · NCT01664494
An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer, Colon Cancer in the Adjuvant Setting, Advanced Gastric Cancer or Breast Cancer
NCT01664494, Completed, Hoffmann-La Roche; results first posted 2016-05-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer, Colon Cancer in the Adjuvant Setting, Advanced Gastric Cancer or Breast Cancer. Trials, record NCT01664494. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01664494
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer, Colon Cancer in the Adjuvant Setting, Advanced Gastric Cancer or Breast Cancer
- NCT number
- NCT01664494
- Status
- Completed
- Enrollment
- 563 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Breast Cancer, Colorectal Cancer, Gastric Cancer
- Interventions
- Capecitabine
- First posted
- 2012-08-14
- Last updated
- 2016-05-02
- Results first posted
- 2016-05-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment | Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first | Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed. |
| Secondary | Median Dose of Capecitabine | Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first | Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented. |
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 | Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment | Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first | All enrolled participants were considered for this outcome measure. | Participants | NUMBER |
| SECONDARY | Median Dose of Capecitabine | Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first | All enrolled participants were considered for this outcome measure. | Milligrams | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment | Capecitabine | Adjuvant therapy | 220 | Participants | |
| Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment | Capecitabine | First line therapy | 176 | Participants | |
| Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment | Capecitabine | Second line therapy | 89 | Participants | |
| Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment | Capecitabine | Third line therapy | 78 | Participants | |
| Median Dose of Capecitabine | Capecitabine | Month 7 | 3500 | Full Range 1500 to 5000 | Milligrams |
| Median Dose of Capecitabine | Capecitabine | From Month 8 onwards | 3000 | Full Range 900 to 5000 | Milligrams |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Capecitabine | 563 | |
| Overall Study | COMPLETED | Capecitabine | 370 | |
| Overall Study | NOT COMPLETED | Capecitabine | 193 |
Source ClinicalTrials.gov
Adverse events43
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 | Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | Capecitabine | 172 | 563 | |
| other | Diarrhoea | Gastrointestinal disorders | Capecitabine | 117 | 563 | |
| other | Nausea | Gastrointestinal disorders | Capecitabine | 110 | 563 | |
| other | Stomatitis | Gastrointestinal disorders | Capecitabine | 63 | 563 | |
| other | Vomiting | Gastrointestinal disorders | Capecitabine | 31 | 563 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Capecitabine | 1 | 563 | |
| serious | Atrial fibrillation | Cardiac disorders | Capecitabine | 1 | 563 | |
| serious | Cardiac arrest | Cardiac disorders | Capecitabine | 1 | 563 | |
| serious | Cardiac failure | Cardiac disorders | Capecitabine | 1 | 563 | |
| serious | Cardiopulmonary failure | Cardiac disorders | Capecitabine | 1 | 563 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Capecitabine | ||
| Total, other adverse events | Capecitabine | 271 | 563 |
| Total, serious adverse events | Capecitabine | 34 | 563 |
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 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/NCT01664494
GET https://conductscience.org/api/trials/v1/NCT01664494/events?page=2