Thoracal Radiotherapy and Tarceva

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if erlotinib given orally along with concurrent palliative irradiation to lung cancer improves local control compared to those treated with radiotherapy alone.

Detailed Description
-----------------
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 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, improve 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 Trial Design: Open multicenter two-armed randomized phase II trial.

Official Title
-----------------
Concomitant Radiotherapy and Erlotinib in Advanced Lung Cancer

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: Erlotinib
* Radiation: Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Histological or cytological verified NSCLC Palliative radiotherapy to thorax indicated 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 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 Known hypersensitivity to erlotinib or other substances in the erlotinib tablets.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy combined with erlotinib<br>Standard treatment 3 Gy x 10 to lung tumor and mediastinal lymph nodes and erlotinib given concomitantly, 150 mg p.o. daily from the day before radiation, until the last day of radiation. | Drug: Erlotinib<br>* Tarceva daily during radiotherapy course<br>* Other names: Tarceva;Radiation: Radiation<br>* Radiotherapy<br>|
| Active Comparator: Radiotherapy alone<br>Radiotherapy 3 Gy x 10 alone | Radiation: Radiation<br>* Radiotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with progression in radiation field among patients treated with erlotinib combined with radiotherapy compared to radiotherapy alone | Evaluate local control by radiological evaluation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Related Adverse Events grade >3 as Assessed by CTCAE v4.0 | To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy. | 1 year | 
| Overall survival will be measured | To evaluate overall survival in the different groups | 1 year |