Cerebral Metastases of Solid Cancers Clinical Trial
Official title:
Efficacy and Safety of Fractionated Stereotactic Radiotherapy (FSRT) in Comparison to Single Session Radiosurgery in Patients With Larger Brain Metastases (2-4 cm)
| NCT number | NCT03697343 |
| Other study ID # | FSRT-Trial |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | May 18, 2021 |
| Est. completion date | May 2026 |
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)
| Status | Recruiting |
| Enrollment | 382 |
| Est. completion date | May 2026 |
| Est. primary completion date | May 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Age > 18 years, no upper age limit - Karnofsky Performance Score > 50 points - Expected Survival > 3 months - 1-10 cerebral metastases of metastatic solid cancer - Indication for local radiotherapy - Patients must be able to understand the protocol and provide informed consent Exclusion Criteria: - Whole Brain radiotherapy no longer than 6 weeks before the start of stereotactic radiotherapy or planned whole brain radiotherapy after stereotactic radiotherapy - Prior irradiation of the cerebral metastasis that is to be treated in the study - Relevant overlap of prior radiation fields with the metastasis that is to be treated in the study - Metastasis in the brainstem - Contraindication for cerebral MRI - Metastasis that is to be treated in the study can't be visualized in contrast-enhanced T1 MRI sequence - Pregnant or lactating women - Abuse of illicit drugs, alcohol or medication - Patient not able or willing to behave according to protocol - Participation in another clinical trial |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinik für Strahlentherapie Bayreuth | Bayreuth | Bayern |
| Germany | Klinik für Radioonkologie und Strahlentherapie Charité Berlin | Berlin | |
| Germany | Klinik für Strahlentherapie und Radioonkologie | Bonn | Nordrhein-Westfalen |
| Germany | Klink und Praxis für Radioonkologie Chemnitz | Chemnitz | Sachsen |
| Germany | Strahlentherapie Coburg | Coburg | Bayern |
| Germany | Erlangen, Universitätsklinikum Strahlenklinik | Erlangen | |
| Germany | Universitätsklinik und Poliklinik für Strahlentherapie Halle | Halle | Sachsen-Anhalt |
| Germany | Radio-Log Strahlentherapie Hof | Hof | Bayern |
| Germany | Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Jena | Jena | Thüringen |
| Germany | Strahlentherapie Süd Kempten | Kempten | Bayern |
| Germany | Klinik und Poliklinik fu¨r RadioOnkologie und Strahlentherapie München (TUM) | München | Bayern |
| Germany | Klinik und Poliklinik für Strahlentherapie Regensburg | Regensburg | Bayern |
| Germany | Klinik für Strahlentherapie und Radioonkologie Stuttgart | Stuttgart | Baden-Württemberg |
| Lead Sponsor | Collaborator |
|---|---|
| University of Erlangen-Nürnberg Medical School |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | CNS toxicity according to CTCAE v5.0 | CNS toxicity according to CTCAE v5.0 | 12 months | |
| Secondary | 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). | 12 months | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Overall Survival | Overall Survival | 24 months | |
| Secondary | 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 |