Trial · NCT01442155
An Observational Study of Adjuvant Treatment With Capecitabine (Xeloda) in Combination With Oxaliplatin in Participants With Stage III Colon Cancer
NCT01442155, Completed, Hoffmann-La Roche; results first posted 2016-07-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Observational Study of Adjuvant Treatment With Capecitabine (Xeloda) in Combination With Oxaliplatin in Participants With Stage III Colon Cancer. Trials, record NCT01442155. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01442155
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Observational Study of Adjuvant Treatment With Capecitabine (Xeloda) in Combination With Oxaliplatin in Participants With Stage III Colon Cancer
- NCT number
- NCT01442155
- Status
- Completed
- Enrollment
- 74 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Colorectal Cancer
- Interventions
- Capecitabine, Oxaliplatin
- First posted
- 2011-09-28
- Last updated
- 2016-07-07
- Results first posted
- 2016-07-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-Free Survival (Time to Event) | Up to 3 years | Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause). |
| Secondary | Safety: Percentage of Participants With Adverse Events | Up to 3 years | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
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 | Disease-Free Survival (Time to Event) | Up to 3 years | Intent-to-treat (ITT) population included all participants treated with at least one dose of study drug. Here, number of participants analyzed is number evaluable for efficacy. | months | MEDIAN |
| SECONDARY | Safety: Percentage of Participants With Adverse Events | Up to 3 years | Safety population included all participants treated with at least one dose of study drug. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-Free Survival (Time to Event) | Capecitabine + Oxaliplatin | 25 | 95% Confidence Interval 15.1 to 34.9 | months | |
| Safety: Percentage of Participants With Adverse Events | Capecitabine + Oxaliplatin | 39.19 | percentage of participants |
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 + Oxaliplatin | 74 | |
| Overall Study | COMPLETED | Capecitabine + Oxaliplatin | 9 | |
| Overall Study | NOT COMPLETED | Capecitabine + Oxaliplatin | 65 |
Source ClinicalTrials.gov
Adverse events6
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 | Thrombocytopenia | Blood and lymphatic system disorders | Capecitabine + Oxaliplatin | 8 | 74 | |
| other | Diarrhea | Gastrointestinal disorders | Capecitabine + Oxaliplatin | 8 | 74 | |
| other | Nausea | Gastrointestinal disorders | Capecitabine + Oxaliplatin | 5 | 74 | |
| other | Neuropathy peripheral | Nervous system disorders | Capecitabine + Oxaliplatin | 7 | 74 | |
| other | Paresthesia | Nervous system disorders | Capecitabine + Oxaliplatin | 4 | 74 | |
| serious | Respiratory failure | Respiratory, thoracic and mediastinal disorders | Capecitabine + Oxaliplatin | 1 | 74 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Capecitabine + Oxaliplatin | ||
| Total, other adverse events | Capecitabine + Oxaliplatin | 23 | 74 |
| Total, serious adverse events | Capecitabine + Oxaliplatin | 1 | 74 |
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/NCT01442155
GET https://conductscience.org/api/trials/v1/NCT01442155/registered