TPF-Induction Chemotherapy of Oropharyngeal and Cavity of the Mouth Cancer

Local advanced Oropharyngeal and cavity of the mouth Cancer are often treated with a combination of surgery and/or radiation and /or chemotherapy.

Despite of therapy improvement there are only little advances in progression-free survival and overall survival.

Therefore new therapy concepts are needed. The advantage of the induction chemotherapy is the possibility of tumor response assessment during chemotherapy and may present a selection criterion for organ preservation.

In order to minimize the time between chemotherapy and surgery it is important to have an early answer for the tumor response. In this study response will be assessed after the first cycle of chemotherapy. Patients showing no tumor response will be operated at once. The other patients will receive further cycles of chemotherapy.

Toxicity of the induction chemotherapy have to be moderate because surgery should not be delayed.

To improve the tolerance of induction therapy the medication dose isn't given on day 1 every 3 weeks, but is dispersed on day 1 and day 8, q3weeks.

Inclusion criteria

• Histological proven, resectable squamous epithelial carcinoma of the oropharynx and the cavity of the mouth
• R0-resection possible
• All T N2 M0 / all T N3 M0 / if T3 or T4a also N0-1 M0
• Leucocytes > 4000/mm³ bzw. neutrophils > 2000/mm³, thrombocytes > 100000/mm³
• adequate kidney function, defined as serum creatinine und urea in normal range, Creatinine clearance > 60 ml/min
• adequate liver function with glutamate oxaloacetate transaminase (SGOT), glutamate pyruvate transaminase (SGPT) and bilirubin in normal range
• electrolytes in normal range
• risks of anesthesia complications normal or minor increased
• Eastern Cooperative Oncology Group (ECOG) 0-2 / Karnofsky >= 60%
• Age 18 - 80 years
• signed written informed consent
• effective contraception for both male and female subjects if the risk of conception exists

Exclusion criteria

• T1 N0 M0 / T1 N1 M0 / T2 N0 M0 / T2 N1 M0
• Resection without curative intention: primary tumor is not treatable with resection methods
• Infiltration of the lower jaw
• M1 status
• Tumor not measurable with Innovation Center Computer Assisted Surgery (ICCAS) methods
• No prior chemotherapy or radiation (a primary surgery is allowed)
• Metachronous or oder synchronous malignoma (Exception: basal cell carcinoma)
• Life expectance < 3 months
• ECOG > 2; Karnofsky < 60%
• acute infections or fever
• known HIV-infection or other immune suppression
• severe cardio pulmonary concomitant diseases
• chronic disease with continuous therapy (uncontrolled diabetes, rheumatoid arthritis) especially continuous therapy with steroids
• other concomitant diseases which, in the investigator's opinion, would exclude the patient from the study
• Contraindications which permit a therapy with Docetaxel, Cisplatin, 5-FU or radiation therapy
• missing patient's compliance
• regular Follow-up visits not possible
• Pregnancy or lactation period
• legal incapacity or limited legal capacity
• Participation in another clinical trial or administration of a not approved substance within 30 days before registration