Trial · NCT00343083
Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck (GCC 0442)
NCT00343083, Phase 2, Completed, University of Maryland, Baltimore; results first posted 2014-04-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck (GCC 0442). Trials, record NCT00343083. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00343083
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck (GCC 0442)
- NCT number
- NCT00343083
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Cancer of Head and Neck
- Interventions
- Erbitux, Paclitaxel & Carboplatin, Radiation
- First posted
- 2006-06-22
- Last updated
- 2019-08-19
- Results first posted
- 2014-04-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Endpoint is the Local Regional Control Rate Assessed 3 Months Post Completion of Radiation Therapy. | 3 months | The local regional control rate was assessed 3 months post completion of radiation therapy based on either MRI or CT and clinical exam. |
| Secondary | Local Regional Control at 2 Years | 2 years | |
| Secondary | Overall Survival and Disease-free Survival | 3 years (overall) 2 years disease-free | |
| Secondary | Pathological Response to Cetuximab | 2 years | Adding CTX to weekly PC and daily RT. CBC and Chemistry panel blood testing |
| Secondary | Percentage of Participants With Grade 3 Toxicities of Cetuximab | 9 weeks | One of the more serious side effects of cetuximab therapy is the incidence of acne-like rash. This rash rarely leads to dose reductions or termination of therapy. It is generally reversible. Further severe infusion reactions include but are not limited to: fevers, chills, rigors, urticaria, pruritis, rash, hypotension, N/V, HA, bronchospasm, dyspnea, wheezing, angioedema, dizziness, anaphylaxis, and cardiac arrest. Therefore, pretreatment with diphenhydramine 30-60 min. before administration is standard of care. Other common side effects include photosensitivity, hypomagnesemia due to magnesium wasting, and less commonly pulmonary and cardiac toxicity. |
| Secondary | Clinical Complete Response Rate of This Regimen in the Population | 3 months | What is the the complete response (CR) rate at the completion of therapy. |
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 | The Primary Endpoint is the Local Regional Control Rate Assessed 3 Months Post Completion of Radiation Therapy. | 3 months | participants | NUMBER | |
| SECONDARY | Local Regional Control at 2 Years | 2 years | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival and Disease-free Survival | 3 years (overall) 2 years disease-free | percentage of participants | NUMBER | |
| SECONDARY | Pathological Response to Cetuximab | 2 years | participants | NUMBER | |
| SECONDARY | Percentage of Participants With Grade 3 Toxicities of Cetuximab | 9 weeks | percentage of participants | NUMBER | |
| SECONDARY | Clinical Complete Response Rate of This Regimen in the Population | 3 months | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Endpoint is the Local Regional Control Rate Assessed 3 Months Post Completion of Radiation Therapy. | Concurrent Chemo Raditaion Wtih Cetuximab | 43 | participants | ||
| Local Regional Control at 2 Years | Concurrent Chemo Raditaion Wtih Cetuximab | 72 | 38 | percentage of participants | |
| Overall Survival and Disease-free Survival | Concurrent Chemo Raditaion Wtih Cetuximab | overall survival | 59 | 38 | percentage of participants |
| Overall Survival and Disease-free Survival | Concurrent Chemo Raditaion Wtih Cetuximab | disease-free survival | 58 | percentage of participants | |
| Pathological Response to Cetuximab | Concurrent Chemo Raditaion Wtih Cetuximab | 43 | participants | ||
| Percentage of Participants With Grade 3 Toxicities of Cetuximab | Concurrent Chemo Raditaion Wtih Cetuximab | mucositis | 79 | 43 | percentage of participants |
| Percentage of Participants With Grade 3 Toxicities of Cetuximab | Concurrent Chemo Raditaion Wtih Cetuximab | rash | 9 | percentage of participants | |
| Percentage of Participants With Grade 3 Toxicities of Cetuximab | Concurrent Chemo Raditaion Wtih Cetuximab | leukopenia | 19 | percentage of participants | |
| Percentage of Participants With Grade 3 Toxicities of Cetuximab | Concurrent Chemo Raditaion Wtih Cetuximab | neutropenia | 19 | percentage of participants | |
| Percentage of Participants With Grade 3 Toxicities of Cetuximab | Concurrent Chemo Raditaion Wtih Cetuximab | RT dermatisis | 16 | percentage of participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cetuximab (ERBITUX) and Concurrent Carboplatin | 43 | |
| Overall Study | COMPLETED | Cetuximab (ERBITUX) and Concurrent Carboplatin | 22 | |
| Overall Study | NOT COMPLETED | Cetuximab (ERBITUX) and Concurrent Carboplatin | 21 |
Source ClinicalTrials.gov
Adverse events1
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 |
|---|---|---|---|---|---|---|
| serious | Anaphylactic reaction | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Cetuximab (ERBITUX) and Concurrent Carboplatin | 3 | 43 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cetuximab (ERBITUX) and Concurrent Carboplatin | ||
| Total, other adverse events | Cetuximab (ERBITUX) and Concurrent Carboplatin | 0 | 43 |
| Total, serious adverse events | Cetuximab (ERBITUX) and Concurrent Carboplatin | 3 | 43 |
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/NCT00343083
GET https://conductscience.org/api/trials/v1/NCT00343083/registered