Trial · NCT00468169
Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer
NCT00468169, Phase 2, Completed, University of Chicago; results first posted 2019-10-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer. Trials, record NCT00468169. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00468169
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer
- NCT number
- NCT00468169
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 110 participants, actual
- Lead sponsor
- University of Chicago
- Conditions
- Head and Neck Cancer
- Interventions
- Cetuximab, 5-FU, Hydroxyurea, Twice-daily radiation, Cisplatin, Accelerated fraction radiotherapy with concomitant boost
- First posted
- 2007-05-02
- Last updated
- 2019-10-09
- Results first posted
- 2019-10-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | 1 years | Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Primary | Progression Free Survival (PFS) | 2 years | Time from randomization until disease progression or death from any cause. Kaplan-Meier estimate of PFS at 2 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Overall Survival (OS) | 2 years | Time from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years. |
| Secondary | Objective Response Rate to Induction | Post-Induction (8 weeks) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Objective Response Rate to CRT | From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks | Response to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination. |
| Secondary | Residual Lymph Node Disease | Up to 10 weeks | Response to CRT was also assessed by determining if there was evidence of residual lymph node disease by neck dissection, if warranted by the presence of any radiographically large (\>1.5 cm) or focally abnormal lymph node. |
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 | Progression Free Survival (PFS) | 1 years | Probability (%) | NUMBER | |
| PRIMARY | Progression Free Survival (PFS) | 2 years | Probability (%) | NUMBER | |
| SECONDARY | Overall Survival (OS) | 2 years | Probability (%) | NUMBER | |
| SECONDARY | Objective Response Rate to Induction | Post-Induction (8 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Objective Response Rate to CRT | From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Residual Lymph Node Disease | Up to 10 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | A: Cetuximab+FHX | 87.7 | 95% Confidence Interval 76.0 to 94.0 | Probability (%) | |
| Progression Free Survival (PFS) | B: Cetuximab + PX | 92.5 | 95% Confidence Interval 81.1 to 97.1 | Probability (%) | |
| Progression Free Survival (PFS) | A: Cetuximab+FHX | 82.5 | 95% Confidence Interval 71.9 to 91.5 | Probability (%) | |
| Progression Free Survival (PFS) | B: Cetuximab + PX | 84.9 | 95% Confidence Interval 72.1 to 92.2 | Probability (%) | |
| Overall Survival (OS) | A: Cetuximab+FHX | 91.2 | 95% Confidence Interval 80.2 to 96.3 | Probability (%) | |
| Overall Survival (OS) | B: Cetuximab + PX | 94.3 | 95% Confidence Interval 83.5 to 98.1 | Probability (%) | |
| Objective Response Rate to Induction | A: Cetuximab+FHX | Complete Response (CR) | 7 | Participants | |
| Objective Response Rate to Induction | B: Cetuximab + PX | Complete Response (CR) | 4 | Participants | |
| Objective Response Rate to Induction | A: Cetuximab+FHX | Partial Response (PR) | 47 | Participants | |
| Objective Response Rate to Induction | B: Cetuximab + PX | Partial Response (PR) | 41 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A: Cetuximab+FHX | 57 | |
| Overall Study | STARTED | B: Cetuximab + PX | 53 | |
| Overall Study | COMPLETED | A: Cetuximab+FHX | 56 | |
| Overall Study | COMPLETED | B: Cetuximab + PX | 53 | |
| Overall Study | NOT COMPLETED | A: Cetuximab+FHX | 1 | |
| Overall Study | NOT COMPLETED | B: Cetuximab + PX | 0 |
Source ClinicalTrials.gov
Adverse events74
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 | Weight loss | Investigations | A: Cetuximab+FHX | 51 | 57 | |
| other | Weight loss | Investigations | B: Cetuximab + PX | 37 | 53 | |
| other | Neutrophil count decreased | Investigations | A: Cetuximab+FHX | 48 | 57 | |
| other | Neutrophil count decreased | Investigations | B: Cetuximab + PX | 45 | 53 | |
| other | Hemoglobin increased | Investigations | A: Cetuximab+FHX | 43 | 57 | |
| other | Hemoglobin increased | Investigations | B: Cetuximab + PX | 36 | 53 | |
| other | White blood cell decreased | Investigations | A: Cetuximab+FHX | 46 | 57 | |
| other | White blood cell decreased | Investigations | B: Cetuximab + PX | 47 | 53 | |
| other | Platelet count decreased | Investigations | A: Cetuximab+FHX | 13 | 57 | |
| other | Platelet count decreased | Investigations | B: Cetuximab + PX | 13 | 53 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A: Cetuximab+FHX | 14 | 57 |
| Total, all-cause mortality | B: Cetuximab + PX | 9 | 53 |
| Total, other adverse events | A: Cetuximab+FHX | 57 | 57 |
| Total, other adverse events | B: Cetuximab + PX | 53 | 53 |
| Total, serious adverse events | A: Cetuximab+FHX | 7 | 57 |
| Total, serious adverse events | B: Cetuximab + PX | 14 | 53 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| A: Cetuximab+FHX vs B: Cetuximab + PX: Objective Response Rate to CRT | Trial comparisons |
| A: Cetuximab+FHX vs B: Cetuximab + PX: deaths from any cause | Trial comparisons |
| A: Cetuximab+FHX vs B: Cetuximab + PX: Residual Lymph Node Disease | Trial comparisons |
| A: Cetuximab+FHX vs B: Cetuximab + PX: serious adverse events | Trial comparisons |
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/NCT00468169
GET https://conductscience.org/api/trials/v1/NCT00468169/events?page=2