Randomized Phase II Study of two different Regimens of TPF Induction Chemotherapy Regimen followed by Radiation Therapy plus cetuximab (TPF-CET-HART) vs. HART and Cisplatinum, 5-FU (PF-HART) in Patients with Locally Advanced Unresectable Squamous Cell Carcinomas of the Head and Neck. - ICRAT
- Conditions
- Patients with histologically proven unresectable squamous cell carcinoma of the oral cavity, oropharynx and hypopharynx (stage IVa & IVb).
- Registration Number
- EUCTR2010-019347-18-DE
- Lead Sponsor
- Charité - Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Histologically proven unresectable SCC of the oral cavity, oropharynx and hypopharynx (stage IVa & IVa)
Written and signed informed consent
Karnofsky PS > 70 %
Age = 18 years
Curative treatment intent
Adequate bone marrow, hepatic and renal functions as evidenced by the following:
Hematology (Bone marrow):
Neutrophils > 2.0 109/L
Platelets > 100 x 109/L
Hemoglobin > 10 g/dL
Hepatic function
Total serum bilirubin < 1 time the upper normal limit (UNL) of the participating center
ASAT (SGOT) and ALAT (SGPT) < 2.5 x UNL
Alkaline phosphatase < 5 x UNL
Renal function :
serum creatinine (SC) < 120 µmol/L (1.4 mg/dl);
if values are > 120 µmol/L, the creatinine clearance should be > 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows :
weight (kg) x (140 - age)
---------------------------------
K x serum creatinine
serum creatinine in mg/dL:K = 72 in man
K = 85 in woman
serum creatinine in µmol/L:K = 0.814 in man
K = 0.96 in woman
If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing.
All patients require:
dental examination and appropriate dental preservation if needed 1 week prior to the beginning of radiotherapy,
gastric feeding tube and Portal-catheter.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Other neoplasia within the past 5 years with the exception of a controlled skin cancer or in situ” cervix cancer
Unknown primary (CUP), nasopharynx, laryngeal or salivary gland cancer
Distant metastatic disease (M1)
Serious co-morbidity, e.g. arterosclerosis with apoplexy, recent myocardial infarction, high-grade carotic stenoses, unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4, Insulin-dependent diabetes mellitus, uncontrolled hypertension, liver szirrhosis (Quick < 75%, total protein <3.0 g/dl, bilirubine >2mg/ml) or kidney insufficiency (creatinine >1.4 mg/ml, the creatinine clearance should be > 60 ml/min)
patients with ASAT or ALAT > 1.5 UNL associated with alkaline phosphatase > 2.5 UNL are not eligible for the study
Known HIV-infection
Pregnancy or lactation
Women of child-bearing potential with unclear contraception
Previous treatment of the disease with chemotherapy, radiotherapy, EGFR-targeting agents or surgery exceeding biopsy in head and neck
Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
Social situations that limit compliance with study requirements
Deficient dental preservation status or not accomplished wound healing
Legal incapacity
Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 2 and/or ototoxicity grade 2, except if due to trauma or mechanical impairment due to tumor mass
Known allergic/hypersensitivity reaction to any of the components of the treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method