Clinical trial NCT03697343: Fractionated Stereotactic Radiotherapy vs. Single Session Radiosurgery in Patients With Larger Brain Metastases
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cerebral Metastases of Solid Cancers
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, Open-Label, randomized
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to local progression - TTLP
timeFrame: 12 months
Secondary outcomes:
measure: CNS toxicity according to CTCAE v5.0
timeFrame: 12 months
measure: Time to local progression (Volumetric RANO-BM criteria)
timeFrame: 12 months
measure: Quality of Life according to EORTC QLQ-C30
timeFrame: Change from baseline to 3, 6, 12 and 24 months
measure: Local-Progression-Free Survival
timeFrame: 12 months
measure: Overall Survival
timeFrame: 24 months
measure: Quality of Life according to EORTC QLQ-BN20
timeFrame: Change from baseline to 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Klinik für Strahlentherapie und Radioonkologie Stuttgart
state: Baden-Württemberg
city: Bayreuth
country: Germany
facility: Klinik für Strahlentherapie Bayreuth
state: Bayern
city: Coburg
country: Germany
facility: Strahlentherapie Coburg
state: Bayern
city: Hof
country: Germany
facility: Radio-Log Strahlentherapie Hof
state: Bayern
city: Kempten
country: Germany
facility: Strahlentherapie Süd Kempten
state: Bayern
city: München
country: Germany
facility: Klinik und Poliklinik für RadioOnkologie und Strahlentherapie München (TUM)
state: Bayern
city: Regensburg
country: Germany
facility: Klinik und Poliklinik für Strahlentherapie Regensburg
state: Bayern
city: Bonn
country: Germany
facility: Klinik für Strahlentherapie und Radioonkologie
state: Nordrhein-Westfalen
city: Halle
country: Germany
facility: Universitätsklinik und Poliklinik für Strahlentherapie Halle
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: Klink und Praxis für Radioonkologie Chemnitz
state: Sachsen
city: Jena
country: Germany
facility: Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Jena
state: Thüringen
city: Berlin
country: Germany
facility: Klinik für Radioonkologie und Strahlentherapie Charité Berlin
city: Erlangen
country: Germany
facility: Erlangen, Universitätsklinikum Strahlenklinik
Study officials:
affiliation: Universitätsklinikum Erlangen, Strahlenklinik
name: Rainer Fietkau, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Erlangen, Strahlenklinik
name: Florian Putz, PD Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: