TPF Induction Chemotherapy for Locally Advanced and Resectable Oral Squamous Cell Carcinoma

• Status: Completed
• Trial end date: 2015-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally advanced or aggressive cancers, and to improve the chance of eradication of the locoregional lesions by radical surgery and/or radiotherapy. However, there are still debates on the clinical value of induction chemotherapy for patients with advanced and resectable oral squamous cell carcinoma. The hypothesis of this study is that the induction chemotherapy of TPF (docetaxel, cisplatin, and 5-fluorouracil) protocol could benefit the patients with locally advanced oral squamous cell carcinoma. The endpoints of this study are the survival rate, local control, and safety.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Cisplatin; Docetaxel; Fluorouracil

Criteria

Inclusion Criteria:

• Written informed consent prior to any study activities

• Age 18-75 years old

• Histological biopsy confirming oral squamous cell carcinoma (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region)

• Clinical stage III/IVA (T1-2, N1-2, M0 or T3-4, N0-2, M0, UICC 2002), resectable lesions

• Karnofsky performance status (KPS) > 60

• Adequate hematologic function: white blood cell > 3,000/mm^3, hemoglobin > 8g/L, platelet count > 80,000/mm^3

• Hepatic function: ALAT/ASAT < 2.5 times the upper limit of normal (ULN), bilirubin < 1.5 times ULN

• Renal function: serum creatinine < 1.5 x ULN

• Life expectancy ≥ 6 months

Exclusion Criteria:

• Evidence of distant metastatic disease and other cancers

• Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment

• Previous radiotherapy for the primary tumor or lymph nodes

• Prior chemotherapy or immunotherapy for the primary tumor

• Other previous malignancy within 5 years

• Systematic diseases history of severe pulmonary or cardiac diseases

• Creatinine Clearance < 30 ml/min

• Legal incapacity or limited legal capacity

• Pregnancy (confirmed by serum or urine β-HCG) or lactation period