Evidence map›Paper›PMID 37516835›Full record

ArticleBMC cancer2023

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.

Maria Waltenberger, Denise Bernhardt, Christian Diehl, Jens Gempt, Bernhard Meyer, Christoph Straube, Benedikt Wiestler, Jan J Wilkens, Claus Zimmer, Stephanie E Combs

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05160818 (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), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05160818 naunknown statusnot on this map

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

TypeinterventionalSponsorTechnical University of MunichRan2021 to 2025Enrolled126ConditionsBrain Metastases, Resection CavityArmsHypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Maria WaltenbergerDepartment of Radiation Oncology, Klinikum rechts der Isar, Technical University of Munich (TUM), Ismaninger Straße 22, 81675, Munich, Germany. maria.waltenberger@mri.tum.de.ORCID http://orcid.org/0000-0002-8064-0010
Denise BernhardtDepartment of Radiation Oncology, Klinikum rechts der Isar, Technical University of Munich (TUM), Ismaninger Straße 22, 81675, Munich, Germany.
Christian DiehlDepartment of Radiation Oncology, Klinikum rechts der Isar, Technical University of Munich (TUM), Ismaninger Straße 22, 81675, Munich, Germany.
Jens GemptDepartment of Neurosurgery, Klinikum rechts der Isar, Technical University of Munich (TUM), Ismaninger Straße 22, 81675, Munich, Germany.
Bernhard MeyerDepartment of Neurosurgery, Klinikum rechts der Isar, Technical University of Munich (TUM), Ismaninger Straße 22, 81675, Munich, Germany.
Christoph StraubeRADIO-LOG Hof, Eppenreuther Straße 9, 95032, Hof, Germany.
Benedikt WiestlerInstitute of Neuroradiology, Klinikum rechts der Isar, Technical University of Munich (TUM), Ismaninger Straße 22, 81675, Munich, Germany.
Jan J WilkensDepartment of Radiation Oncology, Klinikum rechts der Isar, Technical University of Munich (TUM), Ismaninger Straße 22, 81675, Munich, Germany.
Claus ZimmerInstitute of Neuroradiology, Klinikum rechts der Isar, Technical University of Munich (TUM), Ismaninger Straße 22, 81675, Munich, Germany.
Stephanie E CombsDepartment of Radiation Oncology, Klinikum rechts der Isar, Technical University of Munich (TUM), Ismaninger Straße 22, 81675, Munich, Germany.
TUM Klinikum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe brain is a common site for cancer metastases. In case of large and/or symptomatic brain metastases, neurosurgical resection is performed. Adjuvant radiotherapy is a standard procedure to minimize the risk of local recurrence and is increasingly performed as local stereotactic radiotherapy to the resection cavity. Both hypofractionated stereotactic radiotherapy (HFSRT) and single fraction stereotactic radiosurgery (SRS) can be applied in this case. Although adjuvant stereotactic radiotherapy to the resection cavity is widely used in clinical routine and recommended in international guidelines, the optimal fractionation scheme still remains unclear. The SATURNUS trial prospectively compares adjuvant HFSRT with SRS and seeks to detect the superiority of HFSRT over SRS in terms of local tumor control.

methodsIn this single center two-armed randomized phase III trial, adjuvant radiotherapy to the resection cavity of brain metastases with HFSRT (6 - 7 × 5 Gy prescribed to the surrounding isodose) is compared to SRS (1 × 12-20 Gy prescribed to the surrounding isodose). Patients are randomized 1:1 into the two different treatment arms. The primary endpoint of the trial is local control at the resected site at 12 months. The trial is based on the hypothesis that HFSRT is superior to SRS in terms of local tumor control. DISCUSSION: Although adjuvant stereotactic radiotherapy after resection of brain metastases is considered standard of care treatment, there is a need for further prospective research to determine the optimal fractionation scheme. To the best of our knowledge, the SATURNUS study is the only randomized phase III study comparing different regimes of postoperative stereotactic radiotherapy to the resection cavity adequately powered to detect the superiority of HFSRT regarding local control.

trial registrationThe study was retrospectively registered with ClinicalTrials.gov, number NCT05160818, on December 16, 2021. The trial registry record is available on  https://clinicaltrials.gov/study/NCT05160818 . The presented protocol refers to version V1.3 from March 21, 2021.

Indexed as

Brain NeoplasmsRadiosurgeryAdjuvants, ImmunologicBrainClinical Trials, Phase III as TopicDose Fractionation, RadiationEquivalence Trials as TopicHumansRadiation Dose HypofractionationRandomized Controlled Trials as TopicAdjuvants, ImmunologicBrain metastasesClinical trialLocal controlRadiosurgeryRandomized trialResection cavityStereotactic radiotherapy

Identifiers

PMID37516835
PMCPMC10385881
OpenAlexW4385381910

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.