Head and Neck Cancer
Conditions
Keywords
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
Brief summary
RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving cetuximab together with stereotactic radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how giving cetuximab together with stereotactic radiation therapy works in treating patients with recurrent squamous cell carcinoma of the head and neck cancer that cannot be removed by surgery.
Detailed description
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.
Interventions
BIOLOGICALcetuximab
RADIATIONstereotactic body radiation therapy
Sponsors
Centre Oscar Lambret
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with nonprogressive disease at 12 months according to RECIST criteria | — |
Countries
France
Contacts
STUDY_CHAIREric Lartigau, MD, PhD
Centre Oscar Lambret
Outcome results
None listed