Status:
TERMINATED
Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
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...
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. Seconda...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00891904
Start Date
April 1 2009
Last Update
April 14 2016
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001