A Phase 3 interventional study of Radiosurgery and Fractionated stereotactic radiotherapy in Cerebral Metastases of Solid Cancers, sponsored by University of Erlangen-Nürnberg Medical School. Status unknown at 13 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-13.
Sponsored by University of Erlangen-Nürnberg Medical School · Phase 3, Interventional, and Treatment
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.
University of Erlangen-Nürnberg Medical School is the lead sponsor of 275 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
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
Radiation: Radiosurgery
Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm margin
Radiation: Fractionated stereotactic radiotherapy
Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm)
Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm
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.
Time frame: 12 months
CNS toxicity according to CTCAE v5.0
CNS toxicity according to CTCAE v5.0
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 12 months
Overall Survival
Overall Survival
Time frame: 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
Time frame: Change from baseline to 3, 6, 12 and 24 months
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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