Cerebral Metastases of Solid CancersPhase 3NCT03697343
Fractionated Stereotactic Radiotherapy vs. Single Session Radiosurgery in Patients With Larger Brain Metastases
A Phase 3 study testing Radiosurgery and Fractionated stereotactic radiotherapy in people with Cerebral Metastases of Solid Cancers, run by University of Erlangen-Nürnberg Medical School at 13 sites in Germany.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Metastases of Solid Cancers
- What is being tested?
- Radiosurgery and Fractionated stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 13 sitesGermany
- Study dates
- 18 May 2021to May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites, 13 recruiting
- Recruiting
Klinik für Strahlentherapie Bayreuth
Bayreuth, Bavaria, 95445
Ludwig Keilholz, Prof. Dr., 0921 400-6802
- Recruiting
Klinik für Radioonkologie und Strahlentherapie Charité Berlin
Berlin, 13353
Felix Ehret, Dr. med., +49 30 450 527 152, melita.dimitrijevic@charite.de
- Recruiting
Klinik für Strahlentherapie und Radioonkologie
Bonn, North Rhine-Westphalia, 53127
Christopher Schmeel, PD Dr., +49 228 287-10354, Anmeldung.Strahlentherapie@ukbonn.de
- Recruiting
Klink und Praxis für Radioonkologie Chemnitz
Chemnitz, Saxony, 09113
Gunther Klautke, PD Dr. med.
- Recruiting
Strahlentherapie Coburg
Coburg, Bavaria, 96450
Gerhard Grabenbauer, Prof. Dr., 09561 2491-0, strahlentherapie@diacura.de
- Recruiting
Erlangen, Universitätsklinikum Strahlenklinik
Erlangen, 91054
Rainer Fietkau, Prof., +499131-85-33405, rainer.fietkau@uk-erlangen.de
- Recruiting
Universitätsklinik und Poliklinik für Strahlentherapie Halle
Halle, Saxony-Anhalt, 06120
Christian Dietzel, Dr. med., 0345 557 4310, Strahlentherapie@uk-halle.de
- Recruiting
Radio-Log Strahlentherapie Hof
Hof, Bavaria, 95032
Christoph Straube, PD Dr., 09281-140369 0, strahlentherapie-hof@radio-log.de
- Recruiting
Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Jena
Jena, Thuringia, 07745
Andrea Wittig, Prof. Dr., 03641/9-328401, strahlentherapie@med.uni-jena.de
- Recruiting
Strahlentherapie Süd Kempten
Kempten (Allgäu), Bavaria, 87439
Sterzing, Prof. Dr., +49(0)831 9607940, info@strahlentherapie-kempten.de
- Recruiting
Klinik und Poliklinik für RadioOnkologie und Strahlentherapie München (TUM)
München, Bavaria, 81675
Denise Bernhardt, PD Dr., +49 89 4140 4501
- Recruiting
Klinik und Poliklinik für Strahlentherapie Regensburg
Regensburg, Bavaria, 93053
Oliver Kölbl, Prof. Dr.
- Recruiting
Klinik für Strahlentherapie und Radioonkologie Stuttgart
Stuttgart, Baden-Wurttemberg, 70174
Marc Münter, Prof. Dr., 0711 278-34201, k.stahl@klinikum-stuttgart.de
About this study
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)
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)
Read the 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.
- Conditions
- Cerebral Metastases of Solid Cancers
- Being tested
- Radiosurgery, Fractionated stereotactic radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiosurgeryRadiation
Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm)
Fractionated stereotactic radiotherapyRadiation
Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Radiosurgery |
| Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm | Other | Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm margin Receives: Radiation: Fractionated stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
CNS toxicity according to CTCAE v5.0
CNS toxicity according to CTCAE v5.0
Measured: 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).
Measured: 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
Measured: 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
Measured: 12 months
Overall Survival
Overall Survival
Measured: 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
Measured: Change from baseline to 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start18 May 2021
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Metastases of Solid CancersStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, Open-Label, randomized
- Masking
- None (open label)
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Fietkau, Prof., Principal investigator, Universitätsklinikum Erlangen, StrahlenklinikFlorian Putz, PD Dr.med., Principal investigator, Universitätsklinikum Erlangen, Strahlenklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697343
- Sponsor's protocol ID
- FSRT-Trial
- Status last verified
- Dec 2022
- First submitted
- 26 Sep 2018
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03697343
- Acronym / sponsor ID
- FSRT-Trial
- Conditions
- Cerebral Metastases of Solid Cancers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, Open-Label, randomized
| Arm | Type | Receives |
|---|---|---|
| Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and | Other | Radiation: RadiosurgeryRadiosurgery 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 | Radiation: Fractionated stereotactic radiotherapyFractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm margin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiosurgeryRadiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) | Radiation | Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and |
| Fractionated stereotactic radiotherapyFractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm | Radiation | Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm |
Primary outcome
Time to local progression - TTLP
Time frame: 12 months
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.
6 secondary outcomes
CNS toxicity according to CTCAE v5.0
Time frame: 12 months
Time to local progression (Volumetric RANO-BM criteria)
Time frame: 12 months
Quality of Life according to EORTC QLQ-C30
Time frame: Change from baseline to 3, 6, 12 and 24 months
Local-Progression-Free Survival
Time frame: 12 months
Overall Survival
Time frame: 24 months
Quality of Life according to EORTC QLQ-BN20
Time frame: Change from baseline to 3, 6, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Fietkau, Prof. principal investigator
Universitätsklinikum Erlangen, Strahlenklinik
Florian Putz, PD Dr.med. principal investigator
Universitätsklinikum Erlangen, Strahlenklinik
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiosurgery and Fractionated stereotactic radiotherapy in people with Cerebral Metastases of Solid Cancers, run by University of Erlangen-Nürnberg Medical School at 13 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florian Putz, PD Dr. med. (++49(0)9131-85-33405, florian.putz@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to local progression - TTLP (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.