Status and phase
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About
A combination therapy of Docetaxel, Cisplatin und 5-Fluorouracil (= TPF) will be used in patients with resectable oropharyngeal and cavity of the mouth cancer. To improve the compatibility of the TPF-induction without decreasing the efficacy the dose will be given on day 1 and 8 instead of applying the whole dose on day 1 every 3 weeks.
In the phase I-part of the trial the optimal therapeutic dose of Docetaxel and Cisplatin will be defined.
In the phase II-part the progression-free survival after 2 years will be assessed in patients treated with the optimal therapeutic dose.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
71 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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