Squamous Cell Carcinoma of the Head and Neck Clinical Trial
Official title:
A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT) and Chemotherapy in Recurrent and Inoperable Squamous Cell Carcinoma (SCC) of the Head and Neck After Radiotherapy Failure
The purpose of this study is to determine if low-dose radiation therapy and the chemotherapy drug paclitaxel is effective in treating head and neck cancer that has returned after treatment with standard radiation therapy alone, but cannot be removed by surgery. The overall total dose received of both the chemotherapy and radiation therapy will be less than that typically given as standard of care; however, the Food and Drug Administration (FDA) has not evaluated the safety and effectiveness of this combination therapy. In addition, this study will gather information about the effects of radiation therapy and chemotherapy on subject's overall quality of life.
This study will evaluate a combination therapy of paclitaxel and LDFRT. The paclitaxel will
be commercially available drug product dispensed by a licensed pharmacist at UAMS.
Radiotherapy will be delivered using either the TomoTherapy Treatment System (TomoTherapy,
Inc.) or the Varian High Energy Linear Accelerator (Varian Medical Systems).
Subjects will undergo CT imaging (to include neck, chest, abdomen and pelvis) as part of the
standard of care approximately 7 to 21 days prior to initiation of this therapy. Additional
CT imaging will be done at UAMS approximately 3 months after completion of protocol therapy
and every 3 months subsequently until progression or completion of the study whichever comes
first. These CT imaging's will be obtained for recurrent tumor evaluation and determination
of the presence or absence of distant metastasis, as part of the standard of care.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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