A multicenter, open label, non-randomised phase II study with induction chemotherapy with Cisplatin and 5-fluorouracil as combined with accelerated radiotherapy and Erbitux for locally advanced unresectable squamous cell carcinoma
- Conditions
- Patient with locally advanced non-resectable squamous cell carcinoma of the head and neck stage III or IV, oral, oropharyngeal, laryngeal or hypopharyngeal cancer, non-resectable.
- Registration Number
- EUCTR2006-002187-25-SE
- Lead Sponsor
- Radiumhemmet, Karolinska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 90
Histologically confirmed squamous cell carcinoma of the head and neck - stage III or IV, oral, oropharyngeal, laryngeal or hypopharyngeal cancer, non-resectable.
Patients must have evaluable and/or measureable disease
Age =18 years
Performance status (WHO) of 0-1.
Patient must have a life expectancy of at least 3 months allowing adequate follow-up of toxicity evaluation.
Previously untreated with chemo-, immuno- or radiotherapy
Adequate hematological function defined as WBC =3 x 109/litre and platelets =100 x 109litre, ANC ³1.5 x 109litre and HB > 100 g/L
Adequate renal function defined as creatinine clearence = 50 ml/min
Written informed consent must be obtained according to the local Ethics Committee requirements.
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
Patient with distant metastatic disease
Oral stage I-II, oropharyngeal ca T1-T2 or N0-N1, nasopharyngeal, lipcancer, glottic ca stage I-II and cancer of the paranasal sinuses.
Previous or some other concomitant malignancy, less than 5 years, with the exception of adequately treated basal cell skin cancer or in situ cervical cancer
Inability to follow the treatment and evaluation schedule
Any other condition or therapy which in the investigator’s opinion may pose a risk to the patient of interfere with the study objectives
Pregnant or nursing females or patients of child-bearing potential not using adequate methods of birth-control
Patients with active infections or other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment
Known hypersensitivity to any of the components of the treatment
Pre-existing history of severe lung disease
Legal incapacity.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Locoregional tumour control 1 year;Secondary Objective: Overall survival<br>response after induction chemotherapy<br>overall response rate <br>to avaluate safety and toxicity of the treatment<br>to assess quality of life<br>outcome in relation to molecular protein and genetic factors;Primary end point(s): Clinical benefit (CR or, PR or SD) after 12 months.
- Secondary Outcome Measures
Name Time Method