Status:
COMPLETED
Cetuximab and Stereotactic Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
Centre Oscar Lambret
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 c...
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 * ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00738868
Start Date
October 1 2007
Last Update
May 13 2011
Active Locations (1)
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1
Centre Oscar Lambret
Lille, France, 59020