Metastases to BrainNCT02355613
Comparative Evaluation of Two Different Radiosurgery
A study testing Radiosurgery with Gamma Knife Perfexion and Linac-based Radiosurgery with EDGE in people with Metastases to Brain, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Randomized double arm phase III study to evaluate feasibility and safety of Gamma Knife radiosurgery and Linac Based (Edge) radiosurgery in brain metastatic patients Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Metastases to Brain
- What is being tested?
- Radiosurgery with Gamma Knife Perfexion and Linac-based Radiosurgery with EDGE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2014to Jul 2021
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 85 years
- 1 - 4 brain metastases
- Karnofsky performance status (KPS) ≥70
- RPA 1 or 2
- Histopathologically confirmation of primary solid tumor
- Estimated survival ≥ 3 months as GPA score
- Written informed consent
Who cannot join
- Prior WBRT
- Age > 85 years
- KPS < 70
- RPA 3
- Diagnosis of small cell lung cancer (SCLC) or Lymphoproliferative disease
- Use of Avastin for at least 2 months after radiosurgery
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Two Different Radiosurgery Modalities in Brain Metastatic Patients From Several Solid Tumors
Randomized double arm phase III study to evaluate feasibility and safety of Gamma Knife radiosurgery and Linac Based (Edge) radiosurgery in brain metastatic patients
Read the detailed description
This is a prospective double arm phase III study to evaluate cerebral side effects following radiosurgery delivered by Gamma Knife Perfexion and Linac Based EDGE. In particular our primary objective is to evaluate rate of symptomatic radionecrosis from the two different modalities of radiosurgery.
- Conditions
- Metastases to Brain
- Being tested
- Radiosurgery with Gamma Knife Perfexion, Linac-based Radiosurgery with EDGE
- Keywords
- Radiosurgery, brain, metastases
- Medical subject headings
- Brain Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiosurgery with Gamma Knife PerfexionRadiation
Gamma Knife Radiosurgery is a very precise form of therapeutic radiology. Even though it is called surgery, a Gamma Knife procedure does not involve actual surgery but it uses 192 isocentric beams of highly-focused gamma rays (60-Co) to treat small to medium size lesions. Minimum beam size is 4 mm. This procedure is frame based.
Linac-based Radiosurgery with EDGERadiation
EDGE linear accelerator from Varian (Varian, Palo Alto, USA) is a C-arm machine specifically developed for radiosurgery frameless treatment. The characteristics of this linac are a high level of precision and the possibility to include multiple positioning systems for stereotactical treatments, among which Cone Beam CT (CBCT), the Optical Surface Monitoring System (OSMS), and Calypso.
| Study group | Role | What they receive |
|---|---|---|
| Radiosurgery with Gamma Knife Perfexion | Active comparator | A single dose of 24 Gy at 50% isodose will be prescribed at metastases with diameter ≤ 20 mm, while a dose of 20 Gy at 50% isodose will be prescribed for metastases with diameter 21-30 mm Receives: Radiation: Radiosurgery with Gamma Knife Perfexion |
| Linac-based Radiosurgery with EDGE | Active comparator | A single dose of 24 Gy will be prescribed at mean dose to PTV at metastases with diameter ≤ 20 mm, while a dose of 20 Gy will be prescribed for metastases with diameter 21-30 mm Receives: Radiation: Linac-based Radiosurgery with EDGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic radionecrosis
Measured: two years
Secondary outcomes (3)
Local Control of Brain Metastases
Measured: two years
Disease Free survival
Measured: two years
Overall survival
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study start15 Dec 2014
- Primary completionJun 2020
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastases to BrainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
- Investigators
- Marta Scorsetti, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355613
- Sponsor's protocol ID
- 1268
- Status last verified
- May 2022
- First submitted
- 13 Jan 2015
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Scorsetti M, Navarria P, Cozzi L, Clerici E, Bellu L, Franceschini D, Marzo AM, Franzese C, Torri V, Reggiori G, Lobefalo F, Raspagliesi L, Attuati L, Pessina F, Franzini A, Picozzi P, Tomatis S. Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform. Radiat Oncol. 2023 Feb 7;18(1):28. doi: 10.1186/s13014-023-02216-5.
PubMed 36750848
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Two Different Radiosurgery Modalities in Brain Metastatic Patients From Several Solid Tumors
- ClinicalTrials.gov ID
- NCT02355613
- Acronym / sponsor ID
- 1268
- Conditions
- Metastases to Brain
- Keywords
- Radiosurgery, brain, metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 15 Dec 2014 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 4 Feb 2015 (estimated)
- 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.
Randomized double arm phase III study to evaluate feasibility and safety of Gamma Knife radiosurgery and Linac Based (Edge) radiosurgery in brain metastatic patients
Detailed description
This is a prospective double arm phase III study to evaluate cerebral side effects following radiosurgery delivered by Gamma Knife Perfexion and Linac Based EDGE. In particular our primary objective is to evaluate rate of symptomatic radionecrosis from the two different modalities of radiosurgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiosurgery with Gamma Knife Perfexion | Active comparator | Radiation: Radiosurgery with Gamma Knife PerfexionA single dose of 24 Gy at 50% isodose will be prescribed at metastases with diameter ≤ 20 mm, while a dose of 20 Gy at 50% isodose will be prescribed for metastases with diameter 21-30 mm |
| Linac-based Radiosurgery with EDGE | Active comparator | Radiation: Linac-based Radiosurgery with EDGEA single dose of 24 Gy will be prescribed at mean dose to PTV at metastases with diameter ≤ 20 mm, while a dose of 20 Gy will be prescribed for metastases with diameter 21-30 mm |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 - 85 years
- 1 - 4 brain metastases
- Karnofsky performance status (KPS) ≥70
- RPA 1 or 2
- Histopathologically confirmation of primary solid tumor
Key exclusion criteria (7 listed)
- Prior WBRT
- Age > 85 years
- KPS < 70
- RPA 3
- Diagnosis of small cell lung cancer (SCLC) or Lymphoproliferative disease
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 |
|---|---|---|
| Radiosurgery with Gamma Knife PerfexionGamma Knife Radiosurgery is a very precise form of therapeutic radiology. Even though it is called surgery, a Gamma Knife procedure does not involve actual surgery but it uses 192 isocentric beams of highly-focused gamma rays (60-Co) to treat small to medium size lesions. Minimum beam size is 4 mm. This procedure is frame based. | Radiation | Radiosurgery with Gamma Knife Perfexion |
| Linac-based Radiosurgery with EDGEEDGE linear accelerator from Varian (Varian, Palo Alto, USA) is a C-arm machine specifically developed for radiosurgery frameless treatment. The characteristics of this linac are a high level of precision and the possibility to include multiple positioning systems for stereotactical treatments, among which Cone Beam CT (CBCT), the Optical Surface Monitoring System (OSMS), and Calypso. | Radiation | Linac-based Radiosurgery with EDGE |
Primary outcome
Incidence of symptomatic radionecrosis
Time frame: two years
3 secondary outcomes
Local Control of Brain Metastases
Time frame: two years
Disease Free survival
Time frame: two years
Overall survival
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Derived from this study: PubMed 36750848Scorsetti M, Navarria P, Cozzi L, Clerici E, Bellu L, Franceschini D, Marzo AM, Franzese C, Torri V, Reggiori G, Lobefalo F, Raspagliesi L, Attuati L, Pessina F, Franzini A, Picozzi P, Tomatis S. Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform. Radiat Oncol. 2023 Feb 7;18(1):28. doi: 10.1186/s13014-023-02216-5.
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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.
Marta Scorsetti, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiosurgery with Gamma Knife Perfexion and Linac-based Radiosurgery with EDGE in people with Metastases to Brain, run by Istituto Clinico Humanitas 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 4 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic radionecrosis (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02355613, which also lists 1 linked publication.
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 4 May 2022.