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
Abstract Background The 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...
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| Format: | Article |
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BMC
2023-07-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-023-11202-9 |
| _version_ | 1797769415034404864 |
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| author | Maria Waltenberger Denise Bernhardt Christian Diehl Jens Gempt Bernhard Meyer Christoph Straube Benedikt Wiestler Jan J. Wilkens Claus Zimmer Stephanie E. Combs |
| author_facet | Maria Waltenberger Denise Bernhardt Christian Diehl Jens Gempt Bernhard Meyer Christoph Straube Benedikt Wiestler Jan J. Wilkens Claus Zimmer Stephanie E. Combs |
| author_sort | Maria Waltenberger |
| collection | DOAJ |
| description | Abstract Background The 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. Methods In 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 registration The 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. |
| first_indexed | 2024-03-12T21:08:42Z |
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| id | doaj.art-1a4db98d547744ea91eb51d3c5b5fd85 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-03-12T21:08:42Z |
| publishDate | 2023-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-1a4db98d547744ea91eb51d3c5b5fd852023-07-30T11:17:56ZengBMCBMC Cancer1471-24072023-07-0123111010.1186/s12885-023-11202-9Hypofractionated 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 trialMaria Waltenberger0Denise Bernhardt1Christian Diehl2Jens Gempt3Bernhard Meyer4Christoph Straube5Benedikt Wiestler6Jan J. Wilkens7Claus Zimmer8Stephanie E. Combs9Department of Radiation Oncology, Klinikum rechts der Isar, Technical University of Munich (TUM)Department of Radiation Oncology, Klinikum rechts der Isar, Technical University of Munich (TUM)Department of Radiation Oncology, Klinikum rechts der Isar, Technical University of Munich (TUM)Department of Neurosurgery, Klinikum rechts der Isar, Technical University of Munich (TUM)Department of Neurosurgery, Klinikum rechts der Isar, Technical University of Munich (TUM)RADIO-LOG HofInstitute of Neuroradiology, Klinikum rechts der Isar, Technical University of Munich (TUM)Department of Radiation Oncology, Klinikum rechts der Isar, Technical University of Munich (TUM)Institute of Neuroradiology, Klinikum rechts der Isar, Technical University of Munich (TUM)Department of Radiation Oncology, Klinikum rechts der Isar, Technical University of Munich (TUM)Abstract Background The 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. Methods In 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 registration The 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.https://doi.org/10.1186/s12885-023-11202-9Brain metastasesResection cavityLocal controlStereotactic radiotherapyRadiosurgeryClinical trial |
| spellingShingle | Maria Waltenberger Denise Bernhardt Christian Diehl Jens Gempt Bernhard Meyer Christoph Straube Benedikt Wiestler Jan J. Wilkens Claus Zimmer Stephanie E. Combs 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 Brain metastases Resection cavity Local control Stereotactic radiotherapy Radiosurgery Clinical trial |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Brain metastases Resection cavity Local control Stereotactic radiotherapy Radiosurgery Clinical trial |
| url | https://doi.org/10.1186/s12885-023-11202-9 |
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