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

Shanghai Jiao Tong University School of Medicine

Status and phase

Completed

Phase 3

Phase 2

Conditions

Stage IVA Oral Cavity Squamous Cell Carcinoma

Stage III Oral Cavity Squamous Cell Carcinoma

Treatments

Drug: TPF induction chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01542931

TPF for resectable OSCC

2007BAI18B03 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

The primary endpoint of this study is the survival rate (2, 3, 5 years) after induction chemotherapy followed by surgery and radiotherapy. The second endpoint of this study is locoregional control rates (1, 2 years), and the safety.

Enrollment

256 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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