Non-small cell lung cancer, - palliative treatment
Conditions
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 125
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Endpoints: Primary: •To determine if erlotinib given orally along with concurrent external beam radiation therapy, prolongs local tumour control as determined by CT evaluation compared to treatment with external beam radiation therapy alone •To determine whether continued administration of erlotinib prolongs local control Secondary •To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy. •To evaluate if erlotinib along with concurrent external beam radiation therapy, improves quality of life as assessed with the EORTC QLQ-C30 and the EORTC QLQ-LC13. •To evaluate if PET-CT examination can be used to predict response to treatment. •To evaluate overall survival in the different groups ;Secondary Objective: Endpoints: Primary: •To determine if erlotinib given orally along with concurrent external beam radiation therapy, prolongs local tumour control as determined by CT evaluation compared to treatment with external beam radiation therapy alone •To determine whether continued administration of erlotinib prolongs local control Secondary •To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy. •To evaluate if erlotinib along with concurrent external beam radiation therapy, improves quality of life as assessed with the EORTC QLQ-C30 and the EORTC QLQ-LC13. •To evaluate if PET-CT examination can be used to predict response to treatment. •To evaluate overall survival in the different groups ;Primary end point(s): Endpoints: Primary: •To determine if erlotinib given orally along with concurrent external beam radiation therapy, prolongs local tumour control as determined by CT evaluation compared to treatment with external beam radiation therapy alone •To determine whether continued administration of erlotinib prolongs local control Secondary •To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy. •To evaluate if erlotin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Endpoints: Primary: • To determine if erlotinib given orally along with concurrent external beam radiation therapy, prolongs local tumour control as determined by CT evaluation compared to treatment with external beam radiation therapy alone • To determine whether continued administration of erlotinib prolongs local control Secondary • To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy. • To evaluate if erlotinib along with concurrent external beam radiation therapy, improves quality of life as assessed with the EORTC QLQ-C30 and the EORTC QLQ-LC13. • To evaluate if PET-CT examination can be used to predict response to treatment. • To evaluate overall survival in the different groups ;Timepoint(s) of evaluation of this end point: 6-8 weeks after treatment, 12-14 weeks after treatment, 20-26 weeks after treatment, 40-52 weeks after treatment | — |
Countries
Norway
Outcome results
None listed