Concomitant Radiotherapy and Erlotinib in advanced lung cancerThoRaT-studienThoracal Radiotherapy and Tarceva®An open randomized multicenter phase II study
- Conditions
- on-small cell lung cancer, - palliative treatmentTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-000967-25-NO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion crieteria
•Age >18 years
•Histological or cytological verified NSCLC
•ECOG Performance status 0-2
•Fertile patients must use contraception
•Signed informed consent
•Ability to understand and fill in QoL questionnaires
•Capability to take per os medication
•Serum bilirubin < 2 times upper limit of normal (ULN)
•AST and ALT < 2 times ULN (< 5 times ULN if liver metastases are present)
•Creatinine < 5 times ULN
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125
Exclusion criteria
•Pregnancy or nursing
•Other prior or concurrent malignant disease likely to interfere with study treatment or comparisons
•No evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications
•No prior radiotherapy to the same organ / place
•No concurrent treatment with other experimental drugs
•Known brain metastases in need of radiotherapy
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