Head and Neck Cancer
Conditions
Keywords
head and neck cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGCetuximab
400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7
RADIATIONRadiation Therapy
Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab
Sponsors
University of Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically (histologically) proven diagnosis of cutaneous squamous cell carcinoma of the head and neck * Clinical stage \>/= T3 or \>/= N1, M0 including no distant metastases * Gross total resection of the primary tumor with curative intent must be completed within 7 weeks of registration * Performance status of 0-1 within 2 weeks prior to registration * Age \>/= 18 * Adequate labs within 2 weeks prior to registration
Exclusion criteria
* Prior invasive malignancy unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated \< 3 years ago. Patients with a history of T1-2, N0, M0 resected differentiated thyroid carcinoma are considered eligible. * Prior systemic chemotherapy or anti-epidermal growth factor therapy for the study cancer or for a different prior cancer * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Cetuximab and Radiation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 24 |
| other Total, other adverse events | 24 / 24 |
| serious Total, serious adverse events | 3 / 24 |
Outcome results
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.
Time frame: 2 years
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cetuximab and Radiation | Percentage of Participants With Local Regional Control | 91.1 percentage of subjects |
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.
Time frame: 2 years
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cetuximab and Radiation | Percentage of Participants With Disease-free Survival | 70.8 percentage of participants |
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.
Time frame: 5 years
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cetuximab and Radiation | Percentage of Participants With Overall Survival | 56.1 percentage of participants |