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Sponsored by: |
University of Alabama at Birmingham |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00318890 |
This trial seeks to accomplish both local and regional control of head and neck cancer and reduce systemic metastatic disease. To do this, patients will received chemotherapy followed by chemotherapy and radiation (given together) with an escalating dose of docetaxel.
Condition | Intervention | Phase |
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Cancer of Head and Neck Head Cancer Head and Neck Cancer Neck Cancer Neck Neoplasms |
Drug: Cisplatin Drug: Docetaxel Procedure: Radiotherapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 15 |
Study Start Date: | October 2002 |
Study Completion Date: | April 2007 |
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.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The patient has:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 |
Principal Investigator: | Lisle Nabell, M.D. | University of Alabama at Birmingham |
Study ID Numbers: | F020522012, UAB 0210 |
Study First Received: | April 25, 2006 |
Last Updated: | August 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00318890 History of Changes |
Health Authority: | United States: Institutional Review Board |
Chemotherapy and Radiotherapy for Head and Neck Cancer Chemotherapy, Radiotherapy Squamous Cell Carcinoma Head Neck |
Docetaxel Radiation-Sensitizing Agents Amifostine Cisplatin Head and Neck Neoplasms Epidermoid Carcinoma |
Carcinoma, Squamous Cell of Head and Neck Neoplasms, Squamous Cell Squamous Cell Carcinoma Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions Carcinoma Docetaxel Neoplasms Neoplasms by Site |
Radiation-Sensitizing Agents Cisplatin Head and Neck Neoplasms Therapeutic Uses Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |