Clinical trial · Interventional
Comparative Evaluation of Two Different Radiosurgery
Comparative Evaluation of Two Different Radiosurgery Modalities in Brain Metastatic Patients From Several Solid Tumors
NCT02355613CI-TRIAL-00058245completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Randomized double arm phase III study to evaluate feasibility and safety of Gamma Knife radiosurgery and Linac Based (Edge) radiosurgery in brain metastatic patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastases to Brain | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Linac-based Radiosurgery with EDGE | Radiation | — | UNRESOLVED |
| Radiosurgery with Gamma Knife Perfexion | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radiosurgery with Gamma Knife Perfexion
- description
- 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
- interventionNames
- Radiation: Radiosurgery with Gamma Knife Perfexion
- type
- ACTIVE_COMPARATOR
- label
- Linac-based Radiosurgery with EDGE
- description
- 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
- interventionNames
- Radiation: Linac-based Radiosurgery with EDGE
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDScorsetti 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. PMID 36750848