Status:
RECRUITING
Stereotactic Ablative Radiotherapy in Synchronous and Metachronous Oligo-Metastatic Non Small Cell Lung Cancer
Lead Sponsor:
Radiotherapy Oncology Centre "Santa Maria" Hospital
Collaborating Sponsors:
Paola Anselmo,MD
Michelina Casale,PhD
Conditions:
NSCLC
NSCLC Stage IV
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, non-randomized, single arm, single institution phase II trial to evaluate the safety and effectiveness of stereotactic ablative radiotherapy (SABR) in oncogene addicted and non-...
Detailed Description
Targeted Therapies and Immunotherapy have fundamentally changed the treatment of metastatic non-small cell lung cancer (NSCLC). There is an increasing interest in the use of stereotactic ablative rad...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- histologically confirmed NSCLC
- synchronous oligo-M NSCLC as determined by Positron emission tomography- computed tomography (PET/CT) and brain MRI (AJCC 8th edition)
- metachronous oligo-M NSCLC (oligo-persistence, oligo-progressive, oligo-induced) as determined by PET/CT and brain magnetic resonance imaging (MRI) (AJCC 8th edition)
- patients with at least one target to be treated by SABR at the body
- patients with brain metastases synchronous to the body will be enrolled only if amenable to radiosurgery (the number of brain metastases does not enter into the count of the number of oligo-M)
- patients with a previous history of brain metastases will be enrolled only if the previously treated brain metastases are in control
Exclusion
- Ability to understand and the willingness to sign an institutional review board (IRB)- approved informed consent document (either directly or via a legally authorized representative)
- Inability to safely treat target lesions
- Pregnant women are excluded from this study because radiation therapy has known potential for teratogenic or abortifacient effects.
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06207292
Start Date
December 1 2016
End Date
December 1 2024
Last Update
January 16 2024
Active Locations (1)
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1
Radiotherapy Oncology Centre "S.Maria" Hospital
Terni, TR, Italy, 05100