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The standard treatment of surgery followed by radiation therapy can stop tumors from growing in the head and neck region in most patients. However, the cancer can recur or can spread to other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by blocking certain cellular chemical pathways that lead to tumor development. It was approved by the United States Food and Drug Administration (FDA) in 2006 for the treatment of head and neck cancer.
The purpose of this study is to determine how easily cetuximab can be added to treatment with radiation therapy in patients with cutaneous cancer of the head and neck. This study will also look at how well cetuximab added to radiation therapy works over time and how well this treatment is tolerated.
This is a Phase II trial to characterize the feasibility of treating patients with locally advanced cutaneous squamous cell carcinomas of the head and neck with post-operative radiotherapy and cetuximab. Cetuximab has previously been given safely in conjunction with head and neck radiotherapy for mucosal squamous cell carcinoma in multiple phase III trials, and so Phase I data is not necessary here.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetuximab and Radiation | Experimental | Cetuximab 400 mg/m2 IV over 120 minutes loading dose > 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local Regional Control | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease-free Survival | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vinita Takiar, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cetuximab and Radiation | Cetuximab 400 mg/m2 IV over 120 minutes loading dose > 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions Cetuximab: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7 Radiation Therapy: Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cetuximab and Radiation | Cetuximab 400 mg/m2 IV over 120 minutes loading dose > 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions Cetuximab: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7 Radiation Therapy: Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Local Regional Control | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of subjects | 2 years |
|
All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cetuximab and Radiation | Cetuximab 400 mg/m2 IV over 120 minutes loading dose > 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions Cetuximab: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7 Radiation Therapy: Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vinita Takiar, Associate Professor, MD | University of Cincinnati Cancer Center | 513-584-4775 | vinita.takiar@uc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2018 | Dec 6, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Radiation Therapy | Radiation | Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab |
|
| 2 years |
| Percentage of Participants With Overall Survival | 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. | 5 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Cetuximab 400 mg/m2 IV over 120 minutes loading dose > 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions
Cetuximab: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7
Radiation Therapy: Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab
|
|
| Secondary | Percentage of Participants With Disease-free Survival | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
|
|
| Secondary | Percentage of Participants With Overall Survival | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years |
|
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|
| 9 |
| 24 |
| 3 |
| 24 |
| 24 |
| 24 |
| Lip pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Eye disorders - Other, specify | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Eye infection | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Eye pain | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Facial nerve disorder | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Facial pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specify | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Infusion related reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Photosensitivity | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Vascular disorders - Other, specify | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |