Spots Global Cancer Trial Database for A Randomised Phase II Trial of Osimertinib With or Without SRS for EGFR Mutated NSCLC With Brain Metastases
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Trial Identification
Brief Title: A Randomised Phase II Trial of Osimertinib With or Without SRS for EGFR Mutated NSCLC With Brain Metastases
Official Title: A Randomised Phase II Trial of Osimertinib With or Without Stereotactic Radiosurgery for EGFR Mutated Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases
Study ID: NCT03497767
Conditions
Study Description
Brief Summary: 20-40% of patients with NSCLC will develop brain metastases at some point during their course of disease. Osimertinib has demonstrated intracranial activity in EFGR mutated NSCLC with leptomeningeal disease in the phase 1 BLOOM study. Stereotactic radiosurgery (SRS) is one of the standard local treatment for patients with limited number of brain metastases. Currently, it is unclear whether adding SRS to Osimertinib will result in superior intracranial disease control in patients with EGFR mutated NSCLC with brain metastases diagnosed de novo or developed while on first line EGFR tyrosine kinase inhibitors (TKIs) such as Erlotinib and Gefinitib. The aim of this study is to compare the effects of Osimertinib alone versus SRS plus Osimertinib on intra-cranial disease control in EGFR mutated NSCLC with brain metastases diagnosed or developed while on first line EGFR tyrosine kinase inhibitors.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Calvary Mater, Newcastle, New South Wales, Australia
Liverpool Hospital, Sydney, New South Wales, Australia
St. Vincents Hospital, Sydney, New South Wales, Australia
Westmead Hospital, Sydney, New South Wales, Australia
Blacktown Hospital, Sydney, New South Wales, Australia
St George Hospital, Sydney, New South Wales, Australia
Princess Alexandra Hospital, Brisbane, Queensland, Australia
ICON Cancer Centre Greenslopes, Brisbane, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Peter MacCallum Cancer Center, Melbourne, Victoria, Australia
Monash Health, Melbourne, Victoria, Australia
Sir Charles Gairdner, Perth, Western Australia, Australia
National University Hospital, Singapore, , Singapore
Contact Details
Name: Fiona Hegi-Johnson, Dr
Affiliation: Peter MacCallum Cancer Centre, Australia
Role: STUDY_CHAIR
Name: Chee Lee, Dr
Affiliation: National Health and Medical Research Council, Australia
Role: STUDY_CHAIR
Name: Ivan Tham, Dr
Affiliation: National University Hospital, Singapore
Role: STUDY_CHAIR
Name: Yu Yang Soon, Dr
Affiliation: National University Hospital, Singapore
Role: STUDY_CHAIR
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