Cancer Clinical Trial
Official title:
Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer
To determine if erlotinib given orally along with concurrent whole brain irradiation in lung cancer patients with brain metastases improves median overall survival and enhances local control compared to those treated with WBRT alone, without significantly increasing the risk of side effects or lowering quality of life.
Endpoints
Primary:
• 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.
Secondary:
- 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
;
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