Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer (RadEr)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer|
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Radiotherapy alone
Total brain irradiation, 3Gy x10
Whole brain radiation
Other Name: Whole brain radiation therapy
Experimental: Radiation plus erlotinib
Total brain irradiation, 3Gy x10 plus erlotinib 150 mg q d from radiation day -1 through last day of irradiation
Drug: Radiation plus erlotinib
Radiation 3Gy x10 plus erlotinib 150 mg q d, from the day before radiation start, through last day of irradiation
Other Name: Whole brain radiation therapy and tyrosin kinase inhibitor
• To determine if erlotinib given orally along with concurrent WBRT in lung cancer patients with brain metastases, improves median overall survival compared to those treated with WBRT alone.
- To confirm the safety profile of erlotinib along with concurrent WBRT, in the context of treating central nervous system malignancies.
- To evaluate if erlotinib along with concurrent WBRT increases local control rate as measured by MRI at 8 weeks, compared to WBRT alone.
- To evaluate if erlotinib along with concurrent WBRT increases time to neurologic progression of disease based on neuropsychological assessment at baseline, at 8 and 20 weeks after WBRT.
- To evaluate quality of life parameters in patients treated with WBRT alone vs concomitant erlotinib and WBRT
- To evaluate if mutation status has impact on the above mentioned parameters Trial design Open multicenter randomized phase II trial. Patients Patients > 18 years with histologically confirmed NSCLC and brain metastases verified on either CT or MRI, not eligible for neurosurgery or stereotactic radiation therapy.
Trial treatment Patients will be randomized 1:1 to either treatment arm A or B.
- Arm A: WBRT 3 Gy x10 alone.
- Arm B: WBRT 3 Gy x10 and erlotinib given concomitantly, 150 mg p.o. daily from the day before radiation, until the last day of radiation.
Number of patients 150 patients will be included, 75 in each arm
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518621
|The Norwegian Radium Hospital|
|Oslo, Norway, N-0310|
|Principal Investigator:||Odd Terje Brustugun, MD PhD||Norwegian Radium Hospital|