Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
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The primary objectives of this study are to determine the 1-year progression-free survival (PFS) of previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN) treated with radiosurgery and cetuximab and to evaluate the acute and late toxicities associated with the above therapy.
Treatments Administered: - Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy); - Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Administration of cetuximab may or not be the same day that a fraction of SRS is given. Infusion reactions may occurring during the administration of cetuximab and rarely post-infusion.
To determine the 1-year progression-free survival (PFS) of previously irradiated patients with SCCHN treated with radiosurgery and cetuximab; [ Time Frame: 3 years ]
Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy); - Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment
Secondary Outcome Measures :
To evaluate the acute and late toxicities associated with the above therapy. [ Time Frame: 3 years ]
To determine the objective response rate, PFS and overall survival (OS) and to evaluate changes in tumor glucose metabolism post-therapy as assessed by FDG PET Evaluate changes in tumor hypoxia as a result of SRS through assessment by pre-and post-treatment FMISO PET. To determine prognostic factors that may predict the likelihood of locoregional control in patients with recurrent disease treated with radiosurgery and to evaluate the expression of specific biomarkers in tumor before and after treatment and the impact of radiosurgery on the QOL of patients treated for recurrent SCCHN.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histologically proven recurrent squamous cell carcinoma of the head and neck (SCCHN), who has received prior radiotherapy with or without chemotherapy. New primary is allowed if location is in a previously irradiated field. Biopsy is recommended for each recurrence; but is not mandated per study. This will be at the discretion of the principal investigator.
Prior radiation dose of at least 60 Gy.
Disease confined to locoregional site and can be encompassed in a stereotactic radiosurgery "portal"
Tumor must be deemed to be inoperable or unresectable either by clinical or radiographic criteria. These criteria include encasement of great vessels, vertebral invasion or undue peri-operative risk.
Prior surgery for recurrent or new SCCHN is allowed in previously irradiated patients. A minimum of 4 weeks should elapse between any surgery and treatment on study. However, high risk pathologic features should be present, such as positive margins, positive lymphadenopathy, perineural or angiolymphatic invasion. Measurable disease must be present for assessment of response.
Karnofsky performance status > 60 (ECOG 0-2)
Prior treatment with an EGFR Inhibitor is allowed if it was a part of prior curative therapy and was completed at least 30 days prior to commencement of study therapy
Any number of prior chemotherapy regimens are allowed
Measurable disease on imaging studies (MRI, CT, PET-CT or physical exam)
Age > 18
Estimated life expectancy > 12 weeks
No prior radiation therapy or chemotherapy within 1 month of study enrollment
No prior chemotherapy or targeted therapy within the previous 4 weeks
ANC > 1000, PLT>75,000, Serum creatinine<2.5 mg/dL, Bilirubin <1.5 x upper limits of normal (ULN)
Diabetes must be controlled prior to PET-CT scanning (blood glucose <200 mg/dL)
Ability to provide written informed consent
Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies
History of any cancer other than SCCHN (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years.
Patients in their reproductive age group should use an effective method of birth control. Patients who are breast-feeding, or have a positive pregnancy test will be excluded from the study
Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
Concurrent serious infection
History of known hypersensitivity to cetuximab or similar agents