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Phase III trial comparing local control and side effects after fractionated stereotactic radiotherapy and single session radiosurgery in patients with larger brain metastases (2-4 cm)
This is a prospective, multicenter randomized trial comparing local control and side effects after fractionated stereotactic radiotherapy with 12 x 4 Gy and single session radiosurgery according to RTOG 9005 in patients with larger brain metastases (2-4 cm). Patients will be randomized to either fractionated stereotactic radiotherapy with 12 x 4 Gy or radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) as defined by the RTOG 9005. Randomization will be stratified by metastasis volume and histology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and | Other | Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and no margin as defined by the RTOG 9005 |
|
| Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm | Other | Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm margin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiosurgery | Radiation | Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to local progression - TTLP | Local progression will be defined according to the RANO-BM criteria by an increase of at least 20% in the longest diameter of the metastasis relative to nadir or baseline. In addition to the relative increase of 20% the lesion must increase by an absolute value of 5 mm or more. TTLP is defined as the time from randomization until the detection of progression as per the RANO-BM criteria. Patients will be censored if they have no signs of local progression at the time of last tumor monitoring during follow-up or at the onset of one of the following competing risk events not associated with local progression: death, lost to follow up, unauthorized non-protocol treatment of the target lesion. Confirmatory analysis of the primary endpoint variable will be performed using a p-value of p≤0.05 as the global significance level. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| CNS toxicity according to CTCAE v5.0 | CNS toxicity according to CTCAE v5.0 | 12 months |
| Time to local progression (Volumetric RANO-BM criteria) | Based on the RANO-BM criteria, progression is defined as an increase in volume of 72.8% or more (corresponds to a 20% increase in diameter for a perfect sphere). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florian Putz, PD Dr. med. | Contact | ++49(0)9131-85-33405 | florian.putz@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Rainer Fietkau, Prof. | Universitätsklinikum Erlangen, Strahlenklinik | Principal Investigator |
| Florian Putz, PD Dr.med. | Universitätsklinikum Erlangen, Strahlenklinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Strahlentherapie und Radioonkologie Stuttgart | Recruiting | Stuttgart | Baden-Wurttemberg | 70174 | Germany |
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Prospective, multicenter, Open-Label, randomized
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| Fractionated stereotactic radiotherapy | Radiation | Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm |
|
| 12 months |
| Quality of Life according to EORTC QLQ-C30 | Quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ C30 | Change from baseline to 3, 6, 12 and 24 months |
| Local-Progression-Free Survival | Local-Progression-Free Survival is defined like TTLP except that death not associated with local progression will not be censored but assessed as a separate event | 12 months |
| Overall Survival | Overall Survival | 24 months |
| Quality of Life according to EORTC QLQ-BN20 | Quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ BN20 | Change from baseline to 3, 6, 12 and 24 months |
| Klinik für Strahlentherapie Bayreuth | Recruiting | Bayreuth | Bavaria | 95445 | Germany |
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| Strahlentherapie Coburg | Recruiting | Coburg | Bavaria | 96450 | Germany |
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| Radio-Log Strahlentherapie Hof | Recruiting | Hof | Bavaria | 95032 | Germany |
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| Strahlentherapie Süd Kempten | Recruiting | Kempten (Allgäu) | Bavaria | 87439 | Germany |
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| Klinik und Poliklinik für RadioOnkologie und Strahlentherapie München (TUM) | Recruiting | München | Bavaria | 81675 | Germany |
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| Klinik und Poliklinik für Strahlentherapie Regensburg | Recruiting | Regensburg | Bavaria | 93053 | Germany |
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| Klinik für Strahlentherapie und Radioonkologie | Recruiting | Bonn | North Rhine-Westphalia | 53127 | Germany |
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| Klink und Praxis für Radioonkologie Chemnitz | Recruiting | Chemnitz | Saxony | 09113 | Germany |
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| Universitätsklinik und Poliklinik für Strahlentherapie Halle | Recruiting | Halle | Saxony-Anhalt | 06120 | Germany |
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| Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Jena | Recruiting | Jena | Thuringia | 07745 | Germany |
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| Klinik für Radioonkologie und Strahlentherapie Charité Berlin | Recruiting | Berlin | 13353 | Germany |
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| Erlangen, Universitätsklinikum Strahlenklinik | Recruiting | Erlangen | 91054 | Germany |
|
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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