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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of TPF (Docetaxel, Cisplatin, 5-fluorouracil) Induction Chemotherapy Followed by Surgery and Radiotherapy in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma

Conditions
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Stage III Oral Cavity Squamous Cell Carcinoma, Stage IVA Oral Cavity Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: TPF induction chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Surgery and radiotherapy<br>Surgery and post-operative radiotherapy. | |
| Experimental: TPF induction chemotherapy<br>Induction chemotherapy before surgery: docetaxel, cisplatin, and 5-fluorouracil. | Drug: TPF induction chemotherapy<br>* Docetaxel (at a dose of 75mg/m2 of body surface area) was administered as a 2-hour intravenous infusion, followed by intravenous cisplatin (75 mg/m2), administered during a period of 2 to 3 hours. After completion of the cisplatin infusion, 5-Fu (750 mg/m2/day) was administered during a period at least 8 hours for 5 days. Induction chemotherapy was given every 3 weeks for 2 cycles, unless there was disease progression, unacceptable toxic effects, or withdrawal of consent by the patient.<br>* Other names: Followed by surgery and radiotherapy.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | To evaluate the survival rate after TPF induction chemotherapy followed by surgery and radiotherapy. | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local control | To evaluate the 1, 2, 3, 5-year local and regional control rate and distant metastasis rate after TPF indcution chemotherapy followed by surgery and radiotherapy | Up to 5 yeas | 
| Number of participants with adverse events | All adverse events, including serious adverse events, exposure of all study drugs and radiation. | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral squamous cell carcinoma, Induction chemotherapy, Surgery, Radiotherapy