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.
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.
Haddad
Robert
R
Department of Medical Oncology, Head and Neck Division, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA 02115, USA.
Wirth
Lori
L
Costello
Rosemary
R
Weeks
Linda
L
Posner
Marshall
M
D004999:Amifostine / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D017239:Paclitaxel / Q000008:administration & dosage; D011832:Radiation Injuries / Q000517:prevention & control; D011837:Radiation-Protective Agents / Q000627:therapeutic use*; D013280:Stomatitis / Q000209:etiology / Q000517:prevention & control; D014987:Xerostomia / Q000209:etiology / Q000517:prevention & control
D011837:Radiation-Protective Agents; D016190:Carboplatin; D004999:Amifostine; D017239:Paclitaxel