Trial · NCT00069121
A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
NCT00069121, Phase 3, Completed, Hoffmann-La Roche; results first posted 2011-07-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer. Trials, record NCT00069121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00069121
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
- NCT number
- NCT00069121
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,886 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Colorectal Cancer
- Interventions
- Capecitabine, Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU)
- First posted
- 2003-09-18
- Last updated
- 2020-03-06
- Results first posted
- 2011-07-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-Free Survival (DFS) [Number of Events] | Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months). | Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements. |
| Primary | Disease-Free Survival (DFS) [Time to Event] | Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months). | Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements. The median was estimated by the Kaplan-Meier method. The full range values include censored observations. |
| Secondary | Relapse-Free Survival (RFS) [Number of Events] | Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months). | A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment. |
| Secondary | Relapse-Free Survival (RFS) [Time to Event] | Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months). | A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment. The median was estimated by the Kaplan-Meier method. The full range values include censored observations. |
| Secondary | Overall Survival [Number of Events] | Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months). | Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. |
| Secondary | Overall Survival [Time to Event] | Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months). | Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. The median was estimated by the Kaplan-Meier method. The full range values include censored observations. |
| Secondary | Number of Participants With at Least One Adverse Event by Most Severe Intensity | From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days). | The intensity of all adverse events (AEs) was categorized according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) (version 3.0) grading system. If an AE had occurred which was not contained in the NCI-CTC, a four-point scale (mild, moderate, severe, life-threatening) was used. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of an AE in one individual. See the AEs results table for details. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease-Free Survival (DFS) [Number of Events] | Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months). | Intent-to-Treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Relapse-Free Survival (RFS) [Number of Events] | Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months). | Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Disease-Free Survival (DFS) [Time to Event] | Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months). | Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized. | months | MEDIAN |
| SECONDARY | Relapse-Free Survival (RFS) [Time to Event] | Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months). | Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized. | months | MEDIAN |
| SECONDARY | Overall Survival [Number of Events] | Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months). | Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival [Time to Event] | Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months). | Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized. | months | MEDIAN |
| SECONDARY | Number of Participants With at Least One Adverse Event by Most Severe Intensity | From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days). | Safety Population: all participants who were randomized and did receive at least one dose of capecitabine, 5-FU, or oxaliplatin. Participants in the safety population were analyzed according to the study treatment they received. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-Free Survival (DFS) [Number of Events] | 5-FU/LV | Patients with Event | 379 | Participants | |
| Disease-Free Survival (DFS) [Number of Events] | XELOX | Patients with Event | 320 | Participants | |
| Disease-Free Survival (DFS) [Number of Events] | 5-FU/LV | Patients without Events | 563 | Participants | |
| Disease-Free Survival (DFS) [Number of Events] | XELOX | Patients without Events | 624 | Participants | |
| Relapse-Free Survival (RFS) [Number of Events] | 5-FU/LV | Patients With Event | 356 | Participants | |
| Relapse-Free Survival (RFS) [Number of Events] | XELOX | Patients With Event | 290 | Participants | |
| Relapse-Free Survival (RFS) [Number of Events] | 5-FU/LV | Patients Without Events | 586 | Participants | |
| Relapse-Free Survival (RFS) [Number of Events] | XELOX | Patients Without Events | 654 | Participants | |
| Disease-Free Survival (DFS) [Time to Event] | 5-FU/LV | NA | Full Range 0 to 95 | months | |
| Disease-Free Survival (DFS) [Time to Event] | XELOX | 88.6 | Full Range 0 to 89 | months |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 5-FU/LV | 942 | |
| Overall Study | STARTED | XELOX | 944 | |
| Overall Study | Received Treatment | 5-FU/LV | 926 | |
| Overall Study | Received Treatment | XELOX | 938 | |
| Overall Study | COMPLETED | 5-FU/LV | 575 | |
| Overall Study | COMPLETED | XELOX | 619 | |
| Overall Study | NOT COMPLETED | 5-FU/LV | 367 | |
| Overall Study | NOT COMPLETED | XELOX | 325 |
Source ClinicalTrials.gov
Adverse events717
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 | DIARRHOEA | Gastrointestinal disorders | 5-FU/LV MAYO CLINIC | 449 | 657 | |
| other | DIARRHOEA | Gastrointestinal disorders | 5-FU/LV ROSWELL PARK | 219 | 269 | |
| other | DIARRHOEA | Gastrointestinal disorders | XELOX | 577 | 938 | |
| other | NAUSEA | Gastrointestinal disorders | 5-FU/LV MAYO CLINIC | 350 | 657 | |
| other | NAUSEA | Gastrointestinal disorders | 5-FU/LV ROSWELL PARK | 190 | 269 | |
| other | NAUSEA | Gastrointestinal disorders | XELOX | 625 | 938 | |
| other | STOMATITIS ALL | Gastrointestinal disorders | 5-FU/LV MAYO CLINIC | 419 | 657 | |
| other | STOMATITIS ALL | Gastrointestinal disorders | 5-FU/LV ROSWELL PARK | 57 | 269 | |
| other | STOMATITIS ALL | Gastrointestinal disorders | XELOX | 195 | 938 | |
| other | VOMITING | Gastrointestinal disorders | 5-FU/LV MAYO CLINIC | 142 | 657 |
1 to 10 of 717Source ClinicalTrials.gov
See all 717 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 5-FU/LV MAYO CLINIC | 215 | 664 |
| Total, all-cause mortality | 5-FU/LV ROSWELL PARK | 71 | 278 |
| Total, all-cause mortality | XELOX | 242 | 944 |
| Total, other adverse events | 5-FU/LV MAYO CLINIC | 622 | 657 |
| Total, other adverse events | 5-FU/LV ROSWELL PARK | 262 | 269 |
| Total, other adverse events | XELOX | 926 | 938 |
| Total, serious adverse events | 5-FU/LV MAYO CLINIC | 134 | 657 |
| Total, serious adverse events | 5-FU/LV ROSWELL PARK | 88 | 269 |
| Total, serious adverse events | XELOX | 208 | 938 |
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 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/NCT00069121
GET https://conductscience.org/api/trials/v1/NCT00069121/results?page=2