Brain Metastases From NSCLCSTRAITLUCNCT04787185
Stereotactic Radiotherapy in Association With Immunotherapy for the Treatment of NSCLC Brain Metastases
An observational study of Brain Metastases From NSCLC, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases From NSCLC
- What is being tested?
- Valutation of toxicity
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 17 Apr 2020to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with brain metastasis for NSCLC
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Radioterapia Oncologica AOU Careggi
Florence, FI, 50134
Nicola Flego, CTF, 00390557947192, datamanager.gs.rt@sbsc.unifi.it
About this study
Official title: 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).
- Conditions
- Brain Metastases From NSCLC
- Being tested
- Valutation of toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valutation of toxicityRadiation
Observation of toxicity
All patient with Brain metastases from NSCLC who are candidates for RS or HFSRT in course of immunotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start17 Apr 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases From NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Livi, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787185
- Sponsor's protocol ID
- 15901
- Acronym
- STRAITLUC
- Status last verified
- Mar 2021
- First submitted
- 22 Dec 2020
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04787185
- Acronym / sponsor ID
- STRAITLUC / 15901
- Conditions
- Brain Metastases From NSCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with brain metastasis for NSCLC
Key inclusion criteria (20 listed)
- Age> 18 years
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valutation of toxicityObservation of toxicity All patient with Brain metastases from NSCLC who are candidates for RS or HFSRT in course of immunotherapy | Radiation | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases From NSCLC, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.