Stereotactic Radiotherapy in Association With Immunotherapy for the Treatment of NSCLC Brain Metastases

NCT ID: NCT04787185

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-17
• Study Completion Date: 2021-12-01

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 the rate of symptomatic radionecrosis and intralesional hemorrhage. Others primary objectives of the study are the Feasibility and the intracranial control of the disease, both local (site radiotherapy treatment) and at a distance (intracranial, but at a distance from the site of the disease treated with stereotaxic radiotherapy). The secondary objectives concern quality assessment of life of the patients under study (Quality Of Life, QoL).

Conditions

Brain Metastases From NSCLC

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Valutation of toxicity

Observation of toxicity

All patient with Brain metastases from NSCLC who are candidates for RS or HFSRT in course of immunotherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role: lead

Responsible Party

Lorenzo Livi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Radioterapia Oncologica AOU Careggi

Florence, FI, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Nicola Flego, CTF

Role: primary

datamanager.gs.rt@sbsc.unifi.it

00390557947192

Other Identifiers

15901

Identifier Type: -

Identifier Source: org_study_id