Status:
UNKNOWN
Stereotactic Radiotherapy in Association With Immunotherapy for the Treatment of NSCLC Brain Metastases
Lead Sponsor:
Azienda Ospedaliero-Universitaria Careggi
Conditions:
Brain Metastases From NSCLC
Eligibility:
All Genders
18+ years
Brief Summary
The study's primary objective is the evaluation of toxicities reported during RS or HFSRT in patients with brain metastases from NSCLC undergoing immunotherapy (Safety), with particular reference to t...
Eligibility Criteria
Inclusion
- Age\> 18 years
- Ability to express informed consent
- Histological or cytological diagnosis (possibility of PDL-1 determination) of NSCLC
- \- Brain metastases up to a maximum of 10 and all treated with RS or Hypofractionated stereotactic radiotherapy (3 to 5 fractions)
- Brain disease assessable according to iRANO criteria
- Radiation therapy on brain metastases within 4 weeks before or after infusion of immunotherapy in the following settings
- brain metastases at initio brain metastases treated with RS + 1st line therapy
- Brain metastases as I progression after I line of systemic therapy CHT, IT or CHTIT regardless of whether or not the same line is continued (treatment Beyond progression) or shift to the next line;
- Brain metastases as II progression after II line of systemic therapy (CHT, IT) regardless of whether it is continued or not of the same line (treatment beyond progression) or shift to the next line.
- Diagnostic brain MRI for brain metastases within one month of treatment stereotactic
- Esclusion criteria:
- Life expectancy of less than 6 months (calculated with GPA score \<2)
- Performance Status\> 2
- Previous radiotherapy treatment at the brain site
- Contraindication to MRI of the brain with contrast medium
- Presence of a number of intracranial metastases\> 10
- Inability to express informed consent
- Infusion of immunotherapy more than 4 weeks before and after radiotherapy
- Impossibility of recording times and dosages of administration of steroid therapy
- Ineligibility for immunotherapy treatment
Exclusion
- \-
Key Trial Info
Start Date :
April 17 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04787185
Start Date
April 17 2020
End Date
December 1 2021
Last Update
March 8 2021
Active Locations (1)
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1
Radioterapia Oncologica AOU Careggi
Florence, FI, Italy, 50134