Trial · NCT01979211
Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
NCT01979211, Phase 2, Completed, University of Cincinnati; results first posted 2022-05-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck. Trials, record NCT01979211. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01979211
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
- NCT number
- NCT01979211
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- University of Cincinnati
- Conditions
- Head and Neck Cancer
- Interventions
- Cetuximab, Radiation Therapy
- First posted
- 2013-11-08
- Last updated
- 2024-02-29
- Results first posted
- 2022-05-10
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Local Regional Control | 2 years | The primary endpoint of this study was 2-year locoregional control (LRC), defined as no evidence of recurrent cancer in the tumor bed and/or neck as assessed via clinical exam and imaging. Locoregional control was estimated by the Kaplan-Meier method. The Kaplan-Meier method is a statistical method used to assess survival times while factoring for censored observations (those who had LRC) and the time for them to be censored. |
| Secondary | Percentage of Participants With Disease-free Survival | 2 years | The primary endpoint of this study was 2-year disease-free survival (DFS), which was the absence of locoregional recurrence or metastatic disease (biopsied when possible). DFS was estimated by the Kaplan-Meier method. The Kaplan-Meier method is a statistical method used to assess survival times while factoring for censored observations (those who were alive disease-free) and the time for them to be censored. |
| Secondary | Percentage of Participants With Overall Survival | 5 years | The primary endpoint of this study was 5-year overall survival (OS), defined as the absence of death from any cause during those respective time periods. OS was estimated by the Kaplan-Meier method. The Kaplan-Meier method is a statistical method used to assess survival times while factoring for censored observations (those who were alive) and the time for them to be censored. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Local Regional Control | 2 years | 24 data points were included in the Kaplan-Meier method and yielded an predicted percentage of individuals with LRC at a 2 year mark. Analysis yielded a predicted 91% of subjects had LRC. Extrapolating this percentage to the overall number of participants analyzed, 21.84 subjects had LRC. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Participants With Disease-free Survival | 2 years | 24 data points were included in the Kaplan-Meier method and yielded an predicted percentage of individuals with DFS at a 2 year mark. Analysis predicted 70.8% of subjects were alive with no disease. Extrapolating this percentage to the overall number of participants analyzed, 16.99 subjects were alive with no disease. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall Survival | 5 years | 24 data points were included in the Kaplan-Meier method and yielded an predicted percentage of individuals with OS at a 5 year mark. Analysis predicted 56.1% of subjects were alive. Extrapolating this percentage to the overall number of participants analyzed, 13.34 subjects were alive at the 5 year mark. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Local Regional Control | Cetuximab and Radiation | 91.1 | 95% Confidence Interval 80 to 100 | percentage of subjects | |
| Percentage of Participants With Disease-free Survival | Cetuximab and Radiation | 70.8 | 95% Confidence Interval 54.8 to 91.6 | percentage of participants | |
| Percentage of Participants With Overall Survival | Cetuximab and Radiation | 56.1 | 95% Confidence Interval 38.7 to 81.3 | 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 | Cetuximab and Radiation | 24 | |
| Overall Study | COMPLETED | Cetuximab and Radiation | 24 | |
| Overall Study | NOT COMPLETED | Cetuximab and Radiation | 0 |
Source ClinicalTrials.gov
Adverse events63
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 | Abdominal pain | Gastrointestinal disorders | Cetuximab and Radiation | 1 | 24 | 1 |
| other | Acute kidney injury | Renal and urinary disorders | Cetuximab and Radiation | 2 | 24 | 9 |
| other | Alkaline phosphatase increased | Investigations | Cetuximab and Radiation | 1 | 24 | 1 |
| other | Allergic reaction | Immune system disorders | Cetuximab and Radiation | 1 | 24 | 2 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Cetuximab and Radiation | 1 | 24 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Cetuximab and Radiation | 1 | 24 | 4 |
| other | Anorexia | Metabolism and nutrition disorders | Cetuximab and Radiation | 5 | 24 | 28 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Cetuximab and Radiation | 1 | 24 | 1 |
| other | Blurred vision | Eye disorders | Cetuximab and Radiation | 1 | 24 | 11 |
| other | Chills | General disorders | Cetuximab and Radiation | 1 | 24 | 2 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cetuximab and Radiation | 9 | 24 |
| Total, other adverse events | Cetuximab and Radiation | 24 | 24 |
| Total, serious adverse events | Cetuximab and Radiation | 3 | 24 |
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/NCT01979211
GET https://conductscience.org/api/trials/v1/NCT01979211/events?page=2