Open-label, randomised, multi-center study investigating Cetuximab, in combination with concurrent chemo- / radiotherapy in locally advanced non-small cell lung carcinoma
- Conditions
- on-small cell lung cancer locally advanced
- Registration Number
- EUCTR2007-003894-18-NL
- Lead Sponsor
- KI-AV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1.=18 years of age
2.Histologically or cytologically confirmed diagnosis of NSCLC
3.Stage II/III non-operable disease , without malignant pleural effusion
4.Presence of at least one measurable target lesion
5.Acceptable pulmonary function as defined by a Fev1 of =30% and a DLCO of =40% of predicted
6.Life expectancy of at least 6 months
7.WHO performance 0-1
8.Adequate hematological, renal and hepatic functions
a.absolute neutrophil count > 2 x 109/l
b.platelet count > 100 x 109/l
c.total bilirubin < 2 x UNL
d.ASAT/ALAT < = 3 x UNL
e.alkaline phosphatase < 5 x UNL
f.creatinine < 130?mol/l or creatinine clearance > 50ml/min; measured or calculated
g.Urine dipstick for proteinuria < 1+. If urine dipstick is = 1, 24 hour urine must demonstrate < 500 mg of protein in 24 hours.
9.No pre-existing sensory neurotoxicity grade 2 (CTC)
10.Patients of reproductive potential must agree to practice an effective medically approved contraceptive method during the trial and 3 months afterwards
11.Expected risk of radiation-induced pulmonary toxicity is not high:
a.V20 = 36% / MLD = 20Gy (<20% radiation pneumonitis)
12.Signed written informed consent
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
1.Concurrent active malignancy other than localized, nonmelanoma skin cancer or carcinoma-in-situ of the cervix (unless definitive treatment was completed 3 years or more before study entry and the patient had remained disease free);
2.Prior:
a.Ipsilateral radiotherapy to the chest;
b.Chemotherapy within the last 5 years;
c.Immunotherapy or treatment with murine monoclonal antibodies, Cetuximab, or other EGFR inhibitors.
3.Pregnant or breast-feeding patients
4.WHO performance score > 2
5.Other serious diseases, such as heart failure, angina pectoris, myocardial infarction within the last 6 months, uncontrolled hypertension
6.Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
7.Participation in other trial with investigational drug or treatment modality.
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