Stereotactic Radiotherapy in Association With Immunothera... | NCT04787185

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

NCT04787185

Sponsor

Azienda Ospedaliero-Universitaria Careggi

Status

Unknown status

Last Update Posted

Mar 8, 2021Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Brain Metastases From NSCLC

Interventions

Valutation of toxicity

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 17, 2020Actual

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Dec 1, 2021Estimated

First Submitted Date

Dec 22, 2020

First Submission Date that Met QC Criteria

Mar 5, 2021

First Posted Date

Mar 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2021

Last Update Posted Date

Mar 8, 2021Actual

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Valutation of toxicity	Radiation	Observation of toxicity All patient with Brain metastases from NSCLC who are candidates for RS or HFSRT in course of immunotherapy

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	Evaluation of toxicity related to the combination of radiotherapy and immunotherapy	24 Months

Eligibility Module

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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with brain metastasis for NSCLC

Sampling Method

Non-Probability Sample