- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04787185
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
-
-
FI
-
Firenze, FI, Italy, 50134
- Recruiting
- Radioterapia Oncologica AOU Careggi
-
Contact:
- Nicola Flego, CTF
- Phone Number: 00390557947192
- Email: datamanager.gs.rt@sbsc.unifi.it
-
-
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.
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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