Cyclin D1 Based TPF Induction Chemotherapy for Oral Squamous Cell Carcinoma Patients at Clinical N2 Stage
Cyclin D1 Based TPF(Docetaxel, Cisplatin and 5-fluorouracil) Induction Chemotherapy for OSCC(Oral Squamous Cell Carcinoma) Patients at cN2(Clinical Node 2) Stage: a Phase II Randomized Controlled Trial
Shanghai Jiao Tong University School of Medicine
48 participants
Dec 1, 2016
INTERVENTIONAL
Conditions
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 Criteria10
- 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 Criteria8
- 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.
Interventions
The patients in the experimental group received the TPF induction chemotherapy for 2 cycles followed by radical surgery and post-operative radiotherapy. docetaxel:75mg/m2 cisplatin：75 mg/m2 5-Fu：750 mg/m2/day
The patients in the control group received the radical surgery and post-operative radiotherapy.
Radiotherapy was arranged 4 to 6 weeks after surgery. Routine external beam radiotherapy, such as conformal or intensity modulated radiotherapy was performed, and the dose was 1.8-2 Gy/day, 5 days/week for 6 weeks, and totally 54-60 Gy.
Locations(1)
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NCT02290145