A Phase I/II Trial of Induction Cisplatin and Docetaxel Followed by Concomitant Docetaxel/Radiotherapy With Subcutaneous Amifostine for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
The majority of head and neck cancer patients present with more advanced stages III or IV
disease. The treatment of cancers of the head and neck can have profound consequences with
regard to functional abilities such as speech and eating. In the treatment of both locally
advanced HNSCC and sites where organ preservation is desirable, radiation therapy has been a
major method of treatment. However, as a single modality, radiation therapy can cure fewer
than 30% of patients with advanced disease. Attempts to improve the outcome of locally
advanced HNSCC have generally added chemotherapy to radiotherapy. However, the optimal
manner to integrate chemotherapy into the plan of care has been controversial. Chemotherapy
has been used most commonly as either induction therapy preceding radiation, or more
recently as concomitant therapy along with radiation. Induction chemotherapy has been
associated with high response rates of 60-90%, but no significant change in loco-regional
control or survival.Clinical trials incorporating chemotherapy with concurrent radiation
have recently generated considerable interest. To accomplish both loco-regional control and
reduce systemic metastasis, this trial proposes induction chemotherapy followed by
concomitant chemotherapy-radiation with an escalating dose of docetaxel in patients with
locally advanced previously untreated HNSCC.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To establish the response rate to chemotherapy followed by docetaxel with radiotherapy and to assess overall survival, local-regional recurrence rate and effects on the quality of life.
approximately 4 months
Lisle Nabell, M.D.
University of Alabama at Birmingham
United States: Institutional Review Board
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