Phase II randomized study of concomitant chemoradiation using weekly carboplatin/paclitaxel with or without daily subcutaneous amifostine in patients with newly diagnosed locally advanced squamous cell carcinoma of the head and neck.

Author(s): Haddad R, Wirth L, Costello R, Weeks L, Posner M

Affiliation(s): Department of Medical Oncology, Head and Neck Division, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA 02115, USA.

Publication date & source: 2003-12, Semin Oncol., 30(6 Suppl 18):84-8.

Publication type: Clinical Trial; Clinical Trial, Phase II; Randomized Controlled Trial

The treatment of head and neck cancer continues to evolve. The recent use of aggressive chemoradiotherapy protocols has resulted in significant morbidity involving mucositis, dysphagia, and a higher rate of feeding tube dependency. We have initiated a randomized phase II study with concomitant chemoradiotherapy with or without subcutaneous amifostine (Ethyol, WR-2721; MedImmune, Inc, Gaithersburg, MD). This article presents a detailed background, rationale, and endpoints for this study and discusses future directions in the treatment of head and neck cancer.