Niloofar Ahmadloo, Sayed Hasan Hamedi, Samira Razzaghi,Bijan Khademi, Seyed Basir Hashemi, Leila Moaddabshoar,Ahmad Mosalaei Mansour Ansari Shapour Omidvari,Hamid Nasrolahi, Mohammad Mohammadianpanah
Efficacy and Safety of Sequential Chemoradiation with Docetaxel, Cisplatin, and 5-Fluorouracil (TPF) in Treating the Patients with Squamous Cell Carcinoma of the Hypopharynx: A Phase II Clinical Trial
Background: The present study aimed to investigate the efficacy and safety of sequential chemoradiation with docetaxel, cisplatin, and 5-Fluorouracil (TPF) in the patients with Squamous Cell Carcinoma (SCC) of the hypopharynx.
Patients and Methods: In this single arm phase II clinical trial, eligible patients had to have newly diagnosed, locally advanced (T3-T4 and/or N2-N3, M0) hypopharyngeal SCC, no prior therapy, Eastern Cooperative Oncology Group performance scale ≤1, and normal or acceptable organ function. The patients were assigned to receive three cycles of 3-weekly induction chemotherapy in an outpatient setting with docetaxel 75 mg/m2, cisplatin 75 mg/m2, and 5-fluorouracil 750 mg/m2 × 3 days of 8-hour infusion, followed by definite radiotherapy with a total dose of 70 Gy with concurrent cisplatin 30 mg/m2 weekly. Tumor response rates and treatmentrelated toxicity were the primary and secondary study endpoints, respectively.
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