Trial · NCT00079274
Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer
NCT00079274, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2015-02-09
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer. Trials, record NCT00079274. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00079274
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer
- NCT number
- NCT00079274
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,397 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adenocarcinoma of the Colon, Stage III Colon Cancer
- Interventions
- irinotecan hydrochloride, oxaliplatin, leucovorin calcium, fluorouracil, cetuximab, Locally Directed Therapy
- First posted
- 2004-03-10
- Last updated
- 2026-06-23
- Results first posted
- 2015-02-09
- Limitations and caveats
Accrual to arms A and D terminated early based on the results of the planned 2nd interim analysis. Sample sizes limit statistical conclusions for data from the irinotecan treated patients as those treatment arms were discontinued early in the study.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free Survival (Arms A and D: Wild-type KRAS Patients) | At 3 years | The primary endpoint for this study was to compare the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier. |
| Secondary | Disease-free Survival (Arms A and D: Mutant KRAS Patients) | At 3 years | A secondary endpoint for this study was to investigate the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier. |
| Secondary | Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Wild-type KRAS Patients) | Up to 3 years | Evidence of death from any cause within 3 years counted as events in the time to event- Kaplan Meier analysis of overall survival for patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. The 3-year event free rates (percentage) are reported below for Wild-type KRAS Patients. |
| Secondary | Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Mutant KRAS Patients) | Up to 3 years | Evidence of death from any cause within 3 years counted as events in the time to event- Kaplan Meier analysis of overall survival for patients with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. The 3-year event-free rates (percentage) are report below for mutant KRAS patients. |
| Secondary | Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Wild-type KRAS Patients) | Assessed up to 8 years | The maximum grade for each type of toxicity will be recorded for each patient with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below. |
| Secondary | Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Mutant KRAS Patients) | Assessed up to 8 years | The maximum grade for each type of toxicity will be recorded for each patient with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below. |
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 | Disease-free Survival (Arms A and D: Wild-type KRAS Patients) | At 3 years | The analysis was performed using intention to treat principles. All patients that were wild-type KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint. | percentage of participants | NUMBER |
| SECONDARY | Disease-free Survival (Arms A and D: Mutant KRAS Patients) | At 3 years | The analysis was performed using intention to treat principles. All patients that were KRAS mutant (or not evaluable for KRAS) and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Wild-type KRAS Patients) | Up to 3 years | The analysis was performed using intention to treat principles. All patients that were wild-type KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Mutant KRAS Patients) | Up to 3 years | The analysis was performed using intention to treat principles. All patients that were KRAS mutant (or not evaluable for KRAS) and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint. | percentage of participants | NUMBER |
| SECONDARY | Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Wild-type KRAS Patients) | Assessed up to 8 years | All patients that were wild-type KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule and completed the adverse event form at least once were evaluated for this endpoint. | percentage of patients | NUMBER |
| SECONDARY | Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Mutant KRAS Patients) | Assessed up to 8 years | All patients that were mutant KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule and completed the adverse event form at least once were evaluated for this endpoint. | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-free Survival (Arms A and D: Wild-type KRAS Patients) | Wild-type KRAS Arm A | 74.6 | 95% Confidence Interval 71.1 to 78.3 | percentage of participants | |
| Disease-free Survival (Arms A and D: Wild-type KRAS Patients) | Wild-type KRAS Arm D | 71.5 | 95% Confidence Interval 67.8 to 75.4 | percentage of participants | |
| Disease-free Survival (Arms A and D: Mutant KRAS Patients) | Mutant KRAS Arm A | 67.1 | 95% Confidence Interval 61.8 to 72.8 | percentage of participants | |
| Disease-free Survival (Arms A and D: Mutant KRAS Patients) | Mutant KRAS Arm D | 65.0 | 95% Confidence Interval 59.8 to 70.7 | percentage of participants | |
| Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Wild-type KRAS Patients) | Wild-type KRAS Arm A | 87.3 | 95% Confidence Interval 84.3 to 90.3 | percentage of participants | |
| Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Wild-type KRAS Patients) | Wild-type KRAS Arm D | 85.6 | 95% Confidence Interval 82.7 to 88.7 | percentage of participants | |
| Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Mutant KRAS Patients) | Mutant KRAS Arm A | 87.9 | 95% Confidence Interval 84.0 to 91.9 | percentage of participants | |
| Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Mutant KRAS Patients) | Mutant KRAS Arm D | 82.7 | 95% Confidence Interval 78.0 to 87.6 | percentage of participants | |
| Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Wild-type KRAS Patients) | Wild-type KRAS Arm A | 51.1 | percentage of patients | ||
| Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Wild-type KRAS Patients) | Wild-type KRAS Arm D | 73.3 | percentage of patients |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Combination Chemotherapy) | 1,402 | |
| Overall Study | STARTED | Arm B (Combination Chemotherapy) | 111 | |
| Overall Study | STARTED | Arm C (Combination Chemotherapy) | 111 | |
| Overall Study | STARTED | Arm D (Combination Chemotherapy, Monoclonal Antibody) | 1,350 | |
| Overall Study | STARTED | Arm E (Combination Chemotherapy, Monoclonal Antibody) | 45 | |
| Overall Study | STARTED | Arm F (Combination Chemotherapy, Monoclonal Antibody) | 46 | |
| Overall Study | STARTED | Arm G (Locally Directed Therapy) | 332 | |
| Overall Study | COMPLETED | Arm A (Combination Chemotherapy) | 1,081 | |
| Overall Study | COMPLETED | Arm B (Combination Chemotherapy) | 84 | |
| Overall Study | COMPLETED | Arm C (Combination Chemotherapy) | 84 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events2,352
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 | Febrile neutropenia | Blood and lymphatic system disorders | Arm A (Combination Chemotherapy) | 12 | 1,378 | 12 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm B (Combination Chemotherapy) | 2 | 108 | 3 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm C (Combination Chemotherapy) | 3 | 108 | 3 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm D (Combination Chemotherapy, Monoclonal Antibody) | 30 | 1,326 | 33 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm E (Combination Chemotherapy, Monoclonal Antibody) | 1 | 42 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm F (Combination Chemotherapy, Monoclonal Antibody) | 1 | 44 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm G (Locally Directed Therapy) | 0 | 0 | 0 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm A (Combination Chemotherapy) | 6 | 1,378 | 9 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm B (Combination Chemotherapy) | 0 | 108 | 0 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm C (Combination Chemotherapy) | 0 | 108 | 0 |
1 to 10 of 2,352Source ClinicalTrials.gov
See all 2,352 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Combination Chemotherapy) | ||
| Total, all-cause mortality | Arm B (Combination Chemotherapy) | ||
| Total, all-cause mortality | Arm C (Combination Chemotherapy) | ||
| Total, all-cause mortality | Arm D (Combination Chemotherapy, Monoclonal Antibody) | ||
| Total, all-cause mortality | Arm E (Combination Chemotherapy, Monoclonal Antibody) | ||
| Total, all-cause mortality | Arm F (Combination Chemotherapy, Monoclonal Antibody) | ||
| Total, all-cause mortality | Arm G (Locally Directed Therapy) | ||
| Total, other adverse events | Arm A (Combination Chemotherapy) | 688 | 1,378 |
| Total, other adverse events | Arm B (Combination Chemotherapy) | 53 | 108 |
| Total, other adverse events | Arm C (Combination Chemotherapy) | 60 | 108 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers12
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 |
|---|---|---|---|---|---|
| U10CA025224 | North Central Cancer Treatment Group | BUCKNER, JAN C | MAYO CLINIC ROCHESTER | 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/NCT00079274
GET https://conductscience.org/api/trials/v1/NCT00079274/flow?page=2