Hypofractionated Versus Single Fraction Stereotactic Adjuvant Radiotherapy to the Resection Cavity of Brain Metastases
NCT ID: NCT05160818
Last Updated: 2021-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
126 participants
INTERVENTIONAL
2021-02-01
2025-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Based on our own institutional data \[Cit.1\] and a recently published metaanalysis \[Cit.2\], we hypothesize that local control (LC) after HFSRT is superior compared to SRS in terms of LC. To evaluate the hypothesis in a prospective, randomized, controlled setting we designed the SATURNUS study.
A total of 126 patients will be randomized 1:1 to either HFSRT (dose 6-7 x 5 Gy) or SRS (dose 1 x 12-20 Gy). If further unresected brain metastases are present, they will be treated with SRS (1 x 14 - 22 Gy). Irradiation is carried out with a Gamma Knife or a Linear Accelerator. In line with current clinical practice, the choice of positioning method for SRS with the Gamma Knife (mask or stereotactic frame) is left to the patient. In the case of SRS with the Linear Accelerator or HFSRT, fixation is done with a mask as technically not otherwise feasible. Follow-up-MRI will be at least carried out 6 weeks and 3, 6, 9 and 12 months after treatment. Primary endpoint of the study is local control (LC) at the irradiated resection cavity after 12 months. Locoregional control (LRC) and overall survival (OS) as well as salvage-treatments, irradiation-associated toxicities (especially rate of radionecrosis) and quality-of-life parameters are investigated as secondary endpoints.
To the best of our knowledge, the SATURNUS study is the only randomized phase III study comparing different techniques of postoperative stereotactic radiotherapy after resection of brain metastases adequately powered to detect a superiority of HSFRT regarding LC.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A: HSFRT
Hypofractionated stereotactic radiotherapy to the resection cavity, dose prescription: 6-7 x 5 Gy
Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)
intervention description see above
Arm B: SRS
Single fraction stereotactic radiotherapy to the resection cavity, dose prescription: 1 x 12-20 Gy
Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)
intervention description see above
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)
intervention description see above
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* One to three resected brain metastases
* Consent to perform adjuvant irradiation by an interdisciplinary tumor board
* Completed wound healing
* Resection within the last six weeks at the time of study inclusion
* Diameter of the resection cavity ≤ 4 cm (on Planning MRI)
* Age \> 18 years
* KPS \> 60%
* Adequate contraceptive measures for fertile women / men
* Written informed consent (must be available before enrolment in the trial)
Exclusion Criteria
* Leptomeningeal disease
* Small cell histology, hematological malignancies and / or germ cell malignancies
* Previous irradiation of the brain
* Pregnant and lactating women
* Inability to understand the character and consequences of the study
* Withdrawal of consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Technical University of Munich
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Stephanie Combs
Univ.-Prof. Dr. med. Stephanie E. Combs
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maria Waltenberger
Role: STUDY_DIRECTOR
Technical University Munich, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dept. Radiation Oncology
Munich, Bavaria, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Stephanie E. Combs, Prof. Dr.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Specht HM, Kessel KA, Oechsner M, Meyer B, Zimmer C, Combs SE. HFSRT of the resection cavity in patients with brain metastases. Strahlenther Onkol. 2016 Jun;192(6):368-76. doi: 10.1007/s00066-016-0955-2. Epub 2016 Mar 10.
Akanda ZZ, Hong W, Nahavandi S, Haghighi N, Phillips C, Kok DL. Post-operative stereotactic radiosurgery following excision of brain metastases: A systematic review and meta-analysis. Radiother Oncol. 2020 Jan;142:27-35. doi: 10.1016/j.radonc.2019.08.024. Epub 2019 Sep 25.
Waltenberger M, Bernhardt D, Diehl C, Gempt J, Meyer B, Straube C, Wiestler B, Wilkens JJ, Zimmer C, Combs SE. Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiosurgery (SRS) to the resection cavity of brain metastases after surgical resection (SATURNUS): study protocol for a randomized phase III trial. BMC Cancer. 2023 Jul 29;23(1):709. doi: 10.1186/s12885-023-11202-9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RadOnc MRI TUM - 2
Identifier Type: -
Identifier Source: org_study_id