A Randomized Phase II Trial of TPF Induction Chemotherapy in cN2 Patients With Oral Squamous Cell Carcinoma
To confirm the subgroup result from TPF (docetaxel, cisplatin and 5-fluorouracil ) trial (NCT01542931) that cN2 OSCC patients could benefit from TPF induction chemotherapy compared to the standard treatment.
• Age: 18 to 75 years old.
• Sex: both males and females.
• Karnofsky performance status (KPS) \>60.
• Histological biopsy confirming squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region).
• Clinical stage III/IVA (T1-2, N2, M0 or T3-4, N2, M0, UICC\[International Union Against Cancer \]2002) with resectable lesions.
• Adequate hematologic function: white blood cell \>3,000/mm3, hemoglobin\>8g/L, platelet count\>80,000/mm3.
• Hepatic function: ALAT(alanine aminotransferase )/ASAT(aspartate transaminase ) \<2.5 times the upper limit of normal (ULN), bilirubin \<1.5 times ULN.
• Renal function: serum creatinine \<1.5 times ULN.
• Written informed consent