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Randomized double arm phase III study to evaluate feasibility and safety of Gamma Knife radiosurgery and Linac Based (Edge) radiosurgery in brain metastatic patients
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiosurgery with Gamma Knife Perfexion | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic radionecrosis | two years |
| Measure | Description | Time Frame |
|---|---|---|
| Local Control of Brain Metastases | two years | |
| Disease Free survival | two years | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta Scorsetti, MD | Istituto Clinico Humanitas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Clinico Humanitas | Rozzano | MI | 20089 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36750848 | Derived | 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. |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
| Linac-based Radiosurgery with EDGE | Radiation | 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. |
|
| two years |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |