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

March 5, 2021 updated by: Lorenzo Livi, Azienda Ospedaliero-Universitaria Careggi

STRAIT-LUC Trial: Stereotactic Radiotherapy (SRT) in Association With Immunotherapy for the Treatment of Brain Metastases From Non-small Cell Lung Cancer (NSCLC): a Multicenter Prospective Observational Study

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with brain metastasis for NSCLC

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 24 Months
Evaluation of toxicity related to the combination of radiotherapy and immunotherapy
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Careggi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 5, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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