Re-irradiation and Stereotactic Cetuximab in Patients With Recurrent Carcinoma of the Head and Neck
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
Re-irradiation and Stereotactic Cetuximab in Patients With Recurrent Carcinoma of the Head and Neck
OBJECTIVES:
Primary
- Evaluate local control at 12 months in patients with recurrent squamous cell carcinoma
of the head and neck treated with cetuximab and stereotactic radiotherapy.
Secondary
- Determine the incidence of cutaneous toxicity.
- Assess the care and development of skin reactions.
- Determine the quality of life of patients treated with this drug.
- Determine tumor response at 2 months.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV once weekly for 5 weeks. Patients undergo stereotactic
radiotherapy 3 times weekly during weeks 2 and 3.
After completion of study therapy, patients are followed at 2 months and then every 3 months
for 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the head and neck
- Unresectable disease
- Recurrent disease
- No metastatic disease
- Disease in previously irradiated area must be proven by biopsy or imaging
- At least 3 months between prior radiotherapy and diagnosis of recurrent disease
- Surgery or brachytherapy must be possible
- Measurable or evaluable disease by RECIST criteria
- No available curative therapy
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Not pregnant or nursing
- No psychological, familial, social, or geographical reasons that would make
monitoring the patient impossible
- No other malignant disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent participation in another clinical study of an experimental drug
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Percentage of patients with nonprogressive disease at 12 months according to RECIST criteria
Safety Issue:
No
Principal Investigator
Eric Lartigau, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Oscar Lambret
Authority:
United States: Federal Government
Study ID:
CDR0000589673
NCT ID:
NCT00738868
Start Date:
October 2007
Completion Date:
Related Keywords:
- Head and Neck Cancer
- recurrent squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage III verrucous carcinoma of the larynx
- recurrent squamous cell carcinoma of the larynx
- recurrent verrucous carcinoma of the larynx
- recurrent squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the lip and oral cavity
- recurrent verrucous carcinoma of the oral cavity
- stage III verrucous carcinoma of the oral cavity
- recurrent squamous cell carcinoma of the nasopharynx
- stage III squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent salivary gland cancer
- salivary gland squamous cell carcinoma
- stage III salivary gland cancer
- Head and Neck Neoplasms
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