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

• Conditions: Brain Metastases From NSCLC

• Registration Number: NCT04787185
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-17
• Study First Submitted: 2020-12-22
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-05
• Last Update Submitted: 2021-03-05
• Study First Posted: 2021-03-08
• Last Update Posted: 2021-03-08
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients who experience grade 3-5 toxicity within 3 months of initiation, graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0	24 Months	Evaluation of toxicity related to the combination of radiotherapy and immunotherapy

Trial Locations

Locations (1)

Radioterapia Oncologica AOU Careggi; 🇮🇹 Firenze, FI, Italy