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Brain MetastasesSATURNUSNCT05160818

Hypofractionated Versus Single Fraction Stereotactic Adjuvant Radiotherapy to the Resection Cavity of Brain Metastases

A study testing Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS) in people with Brain Metastases and Resection Cavity, run by Technical University of Munich at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This prospective, randomized, controlled, monocentric clinical phase III study focuses on stereotactic irradiation of resection cavities of brain metastases after surgical resection and seeks to demonstrate the superiority of fractionated irradiation schemes in terms of local control. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Metastases, Resection Cavity
What is being tested?
Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteGermany
Study dates
1 Feb 2021to 1 Aug 2025
Phase
Interventional
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

  • Histologically confirmed solid tumor disease
  • 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)
Show all 10Show fewer
  • Age > 18 years
  • KPS > 60%
  • Adequate contraceptive measures for fertile women / men
  • Written informed consent (must be available before enrolment in the trial)

Who cannot join

  • Contraindication for repetitive contrast enhanced MRI
  • 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

Trial locations and contacts

1 site in 1 country.

Maria Waltenberger contact

+49-89-4140-8281

maria.waltenberger@mri.tum.de

Stephanie E Combs, Prof. Dr. contact

+49-89-4140-4501

direktion.radonk@mri.tum.de

Germany1 site, 1 recruiting

  • Dept. Radiation Oncology

    Munich, Bavaria, 81675

    Stephanie E. Combs, Prof. Dr., 089 4140 4501, direktion.radonk@mri.tum.de

    Recruiting

Other trials in Germany

About this study

Official title: Hypofractionated Stereotactic Radiotherapy Versus Single Fraction Stereotactic Radiosurgery to the Resection Cavity of Brain Metastases After Surgical Resection - A Prospective, Randomized, Controlled, Monocentric Phase III Trial

This prospective, randomized, controlled, monocentric clinical phase III study focuses on stereotactic irradiation of resection cavities of brain metastases after surgical resection and seeks to demonstrate the superiority of fractionated irradiation schemes in terms of local control.

Read the detailed description

There is a growing scientific focus on single fraction stereotactic (SRS) and hypofractionated stereotactic irradiation (HFSRT) after surgical resection of brain metastasis and its use is more frequently recommended in international guidelines. Despite intensive research, the optimal fractionation scheme and dose prescription for adjuvant irradiation of the resection cavity remains unclear.

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.

Being tested
Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)
Keywords
Brain Metastases, Resection Cavity, Radiotherapy, Stereotactic Irradiation, Gamma Knife
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)Radiation

    intervention description see above

Study groups in NCT05160818
Study groupRoleWhat they receive
Arm A: HSFRTActive comparatorHypofractionated stereotactic radiotherapy to the resection cavity, dose prescription: 6-7 x 5 Gy
Receives: Radiation: Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)
Arm B: SRSActive comparatorSingle fraction stereotactic radiotherapy to the resection cavity, dose prescription: 1 x 12-20 Gy
Receives: Radiation: Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local control

    Local control at the resected site(s)

    Measured: 12 months after adjuvant radiotherapy

Secondary outcomes (9)

  1. LC

    Local control at all treated site(s)

    Measured: 12 months after adjuvant radiotherapy

  2. LRC

    Locoregional control=CNS progression free survival

    Measured: 12 months after adjuvant radiotherapy

  3. OS

    Overall survival

    Measured: 12 months after adjuvant radiotherapy

  4. Salvage-free survival

    Overall survival

    Measured: 12 months after adjuvant radiotherapy

  5. Intracranial salvage therapy

    Number and kind of intracranial salvage treatments

    Measured: 12 months after adjuvant radiotherapy

  6. Pseudoprogression

    Rate of pseudoprogression

    Measured: up to 12 months after adjuvant radiotherapy

  7. Irradiation-related toxicity

    according to CTCAE v4.03, especially rate of radionecrosis

    Measured: up to 12 months after adjuvant radiotherapy

  8. QoL

    Quality of life according to EORTC QLQ-C30 and EORTC QLQ-B20

    Measured: up to 12 months after adjuvant radiotherapy

  9. Time to loss of independence

    defined as decrease in Barthel index by > 20 points

    Measured: up to 12 months after adjuvant radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2021
  2. Study start1 Feb 2021
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 Parallel Assignment
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05160818
Sponsor's protocol ID
RadOnc MRI TUM - 2
Acronym
SATURNUS
Status last verified
Dec 2021
First submitted
6 Dec 2021
Last updated
16 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26964777

  • 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.

    PubMed 31563407

  • 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.

    PubMed 37516835

Questions about this trial

What is this clinical trial studying?

A study testing Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS) in people with Brain Metastases and Resection Cavity, run by Technical University of Munich at 1 site 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 10 inclusion and 7 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 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

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 Maria Waltenberger (+49-89-4140-8281, maria.waltenberger@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local control (time frame: 12 months after adjuvant radiotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05160818, which also lists 3 linked publications.

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 16 Dec 2021.

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