Trial · NCT02324608
Cetuximab Before Surgery in Treating Patients With Aggressive Locally Advanced Skin Cancer
NCT02324608, Not applicable, Completed, Rutgers, The State University of New Jersey; results first posted 2023-12-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cetuximab Before Surgery in Treating Patients With Aggressive Locally Advanced Skin Cancer. Trials, record NCT02324608. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02324608
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cetuximab Before Surgery in Treating Patients With Aggressive Locally Advanced Skin Cancer
- NCT number
- NCT02324608
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 15 participants, actual
- Lead sponsor
- Rutgers, The State University of New Jersey
- Conditions
- Recurrent Skin Cancer, Squamous Cell Carcinoma of the Skin
- Interventions
- cetuximab, laboratory biomarker analysis
- First posted
- 2014-12-24
- Last updated
- 2023-12-20
- Results first posted
- 2023-12-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate of Cetuximab by RECIST Criteria | Up to 2 years | A one-sided Binomial exact test will be used. |
| Secondary | Progression-free Survival | Up to 2 years | The estimation of progression-free survival will be performed by the Kaplan-Meier product limit method. Descriptive statistics for all outcome measures will be provided. To evaluate the association between variables, either chi-square test (categorical vs. categorical) or two sample t-test (categorical vs. continuous) or correlation (continuous vs. continuous) will be used depending upon the types of variables in comparison. |
| Secondary | Overall Survival | Up to 2 years | The estimation of overall survival will be performed by the Kaplan-Meier product limit method. Descriptive statistics for all outcome measures will be provided. To evaluate the association between variables, either chi-square test (categorical vs. categorical) or two sample t-test (categorical vs. continuous) or correlation (continuous vs. continuous) will be used depending upon the types of variables in comparison. |
| Secondary | Downstream Activation of Signaling Pathways Without a Known Driver, Including the EGFRpathway | Up to 2 years | Measure the downstream activation of signaling pathways without a known driver, including the EGFRpathway |
| Secondary | Potential Markers of Response and/or Resistance to Cetuximab Therapy | Up to 2 years | Analyze the relationship of known DNA mutations in tumor per the FoundationOneTM genomic profile, and correlate to clinical endpoints such as clinical benefit and conversion to resectability to discover potential markers of response and/or resistance to cetuximab therapy. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate of Cetuximab by RECIST Criteria | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Downstream Activation of Signaling Pathways Without a Known Driver, Including the EGFRpathway | Up to 2 years | no data collected | ||
| SECONDARY | Potential Markers of Response and/or Resistance to Cetuximab Therapy | Up to 2 years | no data collected |
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 |
|---|---|---|---|---|---|
| Response Rate of Cetuximab by RECIST Criteria | Treatment (Cetuximab) | 15 | Participants | ||
| Progression-free Survival | Treatment (Cetuximab) | 4 | Participants | ||
| Overall Survival | Treatment (Cetuximab) | 8 | 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 | Treatment (Cetuximab) | 15 | |
| Overall Study | COMPLETED | Treatment (Cetuximab) | 15 | |
| Overall Study | NOT COMPLETED | Treatment (Cetuximab) | 0 |
Source ClinicalTrials.gov
Adverse events44
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 | Rash maculo-papular | Skin and subcutaneous tissue disorders | Treatment (Cetuximab) | 6 | 15 | 7 |
| other | Rash acneiform | Skin and subcutaneous tissue disorders | Treatment (Cetuximab) | 5 | 15 | 8 |
| other | Dry skin | Skin and subcutaneous tissue disorders | Treatment (Cetuximab) | 3 | 15 | 3 |
| other | Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | Treatment (Cetuximab) | 1 | 15 | 1 |
| other | Hypomagnesemia | Metabolism and nutrition disorders | Treatment (Cetuximab) | 9 | 15 | 10 |
| other | Dehydration | Metabolism and nutrition disorders | Treatment (Cetuximab) | 2 | 15 | 2 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Treatment (Cetuximab) | 1 | 15 | 1 |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Cetuximab) | 1 | 15 | 1 |
| other | Hypocalcemia | Metabolism and nutrition disorders | Treatment (Cetuximab) | 1 | 15 | 1 |
| other | Fatigue | General disorders | Treatment (Cetuximab) | 1 | 15 | 1 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Cetuximab) | 8 | 15 |
| Total, other adverse events | Treatment (Cetuximab) | 15 | 15 |
| Total, serious adverse events | Treatment (Cetuximab) | 2 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| P30CA072720 | Cancer Center Support Grant | LIBUTTI, STEVEN K. | RUTGERS BIOMEDICAL AND HEALTH SCIENCES | NATIONAL CANCER INSTITUTE | 1997 to 2025 |
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/NCT02324608
GET https://conductscience.org/api/trials/v1/NCT02324608/events?page=2