Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer
A Feasibility Study of Re-irradiation Using Stereotactic Body Radiation Therapy (SBRT) and Cetuximab for Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving stereotactic body radiation therapy together with cetuximab may kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects of radiation therapy given together with cetuximab and to see how well it works in treating patients with recurrent head and neck cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- To assess the toxicity of stereotactic body radiotherapy delivered concurrently with cetuximab in patients with recurrent squamous cell carcinoma of the head and neck.
Secondary
- To assess the feasibility of delivering this regimen in these patients.
- To assess the impact of this regimen on local control, distant control, and overall survival of these patients.
OUTLINE: Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5. Patients undergo 1 fraction of stereotactic-body radiotherapy (RT) in week 2. At 4 weeks after RT completion, patients may receive additional cetuximab IV combined with a 28-day chemotherapy regimen, per investigator discretion.
After completion of study treatment, patients are followed every 2 months for 1 year, every 3-4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the oral cavity, paranasal sinuses, nasopharynx, larynx, hypopharynx, or oropharynx
- Medically or surgically inoperable disease or patient refuses surgery
- Recurrent disease
Previously irradiated disease meeting the following criteria:
- Prior radiotherapy completed > 6 months from re-irradiation
- Prior radiotherapy in the region of the study cancer that would result in overlap of radiation therapy fields
- Majority of the recurrent tumor volume (> 50%) received prior radiotherapy dose of 30-75 Gy
- No distant metastatic disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 60 days after completion of study treatment
- No prior allergic reaction to study drugs
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior surgical resection of the recurrent primary tumor and/or regional lymphatics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cetuximab
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5
|
Given IV
Undergoing Radiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30
Time Frame: Daily while on Treatment
|
Daily while on Treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients
Time Frame: 2 years
|
2 years
|
|
Local and Distant Control
Time Frame: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter.
|
very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter.
|
|
Overall Survival
Time Frame: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter
|
very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000640992
- RPCI-I-143108
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