Stage III Oral Cavity Squamous Cell Carcinoma, Stage IVA Oral Cavity Squamous Cell Carcinoma
Conditions
Keywords
Oral squamous cell carcinoma, Induction chemotherapy, Surgery, Radiotherapy
Brief 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.
Detailed 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.
Interventions
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.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | Up to 5 years | To evaluate the survival rate after TPF induction chemotherapy followed by surgery and radiotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local control | Up to 5 yeas | 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 |
| Number of participants with adverse events | Up to 5 years | All adverse events, including serious adverse events, exposure of all study drugs and radiation. |
Countries
China
Outcome results
None listed