Cyclin D1 Based TPF Induction Chemotherapy for Oral Squamous Cell Carcinoma Patients at Clinical N2 Stage

Summary

The purpose of this study is to To confirm the predictive value of CCND1 for TPF induction in cN2 patients with OSCC

Eligibility

Inclusion Criteria:

* 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).
* Cyclin D1 high expression
* 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

Exclusion Criteria:

* Evidence of distant metastatic disease and other cancers.
* Surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy).
* Previous radiotherapy or chemotherapy.
* Other previous malignancies within 5 years.
* Can not tolerate the treatment protocol with systematic diseases such as history of severe pulmonary or cardiac diseases.
* Legal incapacity or limited legal capacity.
* Creatinine clearance \<30ml/min.
* Pregnancy (confirmed by serum or urine β-HCG) or lactation period.

Conditions3

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