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Brief Title: Safety Study of Radiotherapy and Concurrent Erlotinib (Tarceva®) for Brain Metastases From a Non-Small Cell Lung Cancer
Official Title: A Phase I Study of Radiotherapy Concurrent With Erlotinib (Tarceva®) in the Treatment of Brain Metastases From Non-Small Cell Lung Cancer (NSCLC)
Study ID: NCT00536861
Brief Summary: Lung cancer is a leading cause of death worldwide. Brain metastases manifest as the first site of disease failure in between 15-30% of patients with non-small cell lung cancer (NSCLC). The standard treatment for patients with multiple brain metastases is whole brain radiotherapy but this results in only a modest survival of 3-6 months. Drugs that can enhance the effect of cranial irradiation (radiosensitizers) may improve the the response rates. Erlotinib (Tarceva) is an oral agent that has been registered for treatment in patients with metastatic NSCLC. Erlotinib has shown tumor activity in patients presenting with brain metastases, and preclinical studies show that it may be a radiosensitizer. As a prelude to studies investigating the combination of Erlotinib and cranial radiotherapy, the present study will be performed to evaluate the safety of combining both these treatments.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
VU University Medical Center, Amsterdam, , Netherlands
Name: Suresh Senan, MD, PhD
Affiliation: Amsterdam UMC, location VUmc
Role: STUDY_CHAIR
Name: Frank J Lagerwaard, MD, PhD
Affiliation: Amsterdam UMC, location VUmc
Role: PRINCIPAL_INVESTIGATOR
Name: Egbert F Smit, MD, PhD
Affiliation: Amsterdam UMC, location VUmc
Role: PRINCIPAL_INVESTIGATOR