Trial · NCT01150045
Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery
NCT01150045, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2021-08-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery. Trials, record NCT01150045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01150045
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery
- NCT number
- NCT01150045
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,527 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Colorectal Cancer
- Interventions
- celecoxib, 5-fluorouracil, placebo, oxaliplatin, leucovorin
- First posted
- 2010-06-24
- Last updated
- 2026-05-19
- Results first posted
- 2021-08-06
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 | At 3 years of follow-up | Disease-Free Survival (DFS) is defined as the time of randomization until documented progression or death from any cause. The endpoint of this trial is to compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX; Arm A and Arm C) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily (Arm B and Arm D). The percentage of patients who were alive and disease free after 3 years are reported here. A log-rank test stratified with the stratification factors was used to compare disease-free survival (celecoxib vs placebo) |
| Secondary | Overall Survival | up to 3 years from registration | Overall Survival (DFS) is defined as the time of randomization until documented death from any cause. The endpoint is to compare overall survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX; Arm A and Arm C) or standard chemotherapy (FOLFOX) with 5 years of celecoxib 400 mg daily (Arm B and Arm D). The percentage of patients who were alive after 3 years are reported here. |
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 | At 3 years of follow-up | All patients that were randomized and evaluable were included in this analysis. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | up to 3 years from registration | All patients that were randomized and evaluable were included in this analysis. | percentage of 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 |
|---|---|---|---|---|---|
| Disease-free Survival | FOLFOX and Placebo (Arms A +C) | 73.4 | 95% Confidence Interval 70.8 to 76.0 | percentage of participants | |
| Disease-free Survival | FOLFOX Plus Celecoxib Daily (Arms B + D) | 76.3 | 95% Confidence Interval 73.8 to 78.8 | percentage of participants | |
| Overall Survival | FOLFOX and Placebo (Arms A +C) | 81.6 | 95% Confidence Interval 79.4 to 83.9 | percentage of participants | |
| Overall Survival | FOLFOX Plus Celecoxib Daily (Arms B + D) | 84.3 | 95% Confidence Interval 82.2 to 86.5 | percentage of participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A - 12 Cycles of FOLFOX Plus Placebo Daily | 615 | |
| Overall Study | STARTED | Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily | 647 | |
| Overall Study | STARTED | Arm C - 6 Cycles of FOLFOX Plus Placebo Daily | 646 | |
| Overall Study | STARTED | Arm D - 6 Cycles of FOLFOX Plus Celecoxib Daily | 618 | |
| Overall Study | COMPLETED | Arm A - 12 Cycles of FOLFOX Plus Placebo Daily | 615 | |
| Overall Study | COMPLETED | Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily | 646 | |
| Overall Study | COMPLETED | Arm C - 6 Cycles of FOLFOX Plus Placebo Daily | 646 | |
| Overall Study | COMPLETED | Arm D - 6 Cycles of FOLFOX Plus Celecoxib Daily | 617 | |
| Overall Study | NOT COMPLETED | Arm A - 12 Cycles of FOLFOX Plus Placebo Daily | 0 | |
| Overall Study | NOT COMPLETED | Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2,148
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 | Blood disorder | Blood and lymphatic system disorders | Arm A - FOLFOX and Placebo (12 Treatments) | 1 | 615 | 1 |
| other | Blood disorder | Blood and lymphatic system disorders | Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily | 4 | 647 | 27 |
| other | Blood disorder | Blood and lymphatic system disorders | Arm C - 6 Cycles of FOLFOX Plus Placebo Daily | 4 | 646 | 15 |
| other | Blood disorder | Blood and lymphatic system disorders | Arm D - 6 Cycles of FOLFOX Plus Celecoxib Daily | 3 | 618 | 5 |
| other | Bone marrow hypocellular | Blood and lymphatic system disorders | Arm A - FOLFOX and Placebo (12 Treatments) | 1 | 615 | 3 |
| other | Bone marrow hypocellular | Blood and lymphatic system disorders | Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily | 0 | 647 | 0 |
| other | Bone marrow hypocellular | Blood and lymphatic system disorders | Arm C - 6 Cycles of FOLFOX Plus Placebo Daily | 0 | 646 | 0 |
| other | Bone marrow hypocellular | Blood and lymphatic system disorders | Arm D - 6 Cycles of FOLFOX Plus Celecoxib Daily | 0 | 618 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm A - FOLFOX and Placebo (12 Treatments) | 9 | 615 | 11 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily | 12 | 647 | 14 |
1 to 10 of 2,148Source ClinicalTrials.gov
See all 2,148 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A - FOLFOX and Placebo (12 Treatments) | 10 | 615 |
| Total, all-cause mortality | Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily | 8 | 647 |
| Total, all-cause mortality | Arm C - 6 Cycles of FOLFOX Plus Placebo Daily | 10 | 646 |
| Total, all-cause mortality | Arm D - 6 Cycles of FOLFOX Plus Celecoxib Daily | 9 | 618 |
| Total, other adverse events | Arm A - FOLFOX and Placebo (12 Treatments) | 574 | 615 |
| Total, other adverse events | Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily | 615 | 647 |
| Total, other adverse events | Arm C - 6 Cycles of FOLFOX Plus Placebo Daily | 618 | 646 |
| Total, other adverse events | Arm D - 6 Cycles of FOLFOX Plus Celecoxib Daily | 589 | 618 |
| Total, serious adverse events | Arm A - FOLFOX and Placebo (12 Treatments) | 77 | 615 |
| Total, serious adverse events | Arm B - 12 Cycles of FOLFOX Plus Celecoxib Daily | 93 | 647 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
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/NCT01150045
GET https://conductscience.org/api/trials/v1/NCT01150045/events?page=2