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Hypofractionated stereotactic radiotherapy to the resection cavity, dose prescription: 6-7 x 5 Gy

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)

Maria Waltenberger

Stephanie E Combs, Prof. Dr.

Stephanie E. Combs, Prof. Dr.

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.

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.

The affiliation to the treatment arm will not be blinded to anyone except the study neuroradiologist.

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

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

Locoregional control=CNS progression free survival

Number and kind of intracranial salvage treatments

according to CTCAE v4.03, especially rate of radionecrosis

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

defined as decrease in Barthel index by \> 20 points

Technical University of Munich

Univ.-Prof. Dr. med. Stephanie E. Combs

18Gy in 1 fraction for resection cavity \<2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity \>4cm in maximum diameter

30Gy in 10 fractions over 12 days to whole brain

stereotactic body radiotherapy (SBRT)

Whole-Brain Radiotherapy (WBRT)

Wojciech Michalski, M.S.

Lucyna Kepka, Prof.

Adjuvant whole-brain radiation therapy (WBRT) after resection of single brain metastasis is considered as a standard associated with side effects leading to decreased neurocognitive function. The Investigators addressed the question whether stereotactic radiotherapy of the resection cavity impairs neurological status and/or cognitive functions in compare to adjuvant WBRT.

Patients with surgically removed single brain metastasis are randomly allocated to control or experimental arm. Before treatment the MRC Neurological Status Scale is used for assessing neurological status, the EORTC QLQ-C30 and QLQ-BN20 for quality of life and Mini-Mental State Examination to assess cognitive functioning. The control group receive 30Gy in 10 fractions of 3Gy over 12 days to the whole brain. The patients in the experimental arm are treated with stereotactic radiotherapy to the resection cavity. The dose to the tumor bed is 15-18Gy in one fraction or 25Gy in 5 fractions. The study hypothesis is that the difference in the 5-months failure free survival rate isn't higher than 25% in experimental arm compared to control arm.

Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection

Phase 3 Study of Stereotactic Radiotherapy of the Postoperative Resection Cavity Versus Whole-Brain Irradiation After Surgical Resection of Single Brain Metastasis

Time to decrease in MRC scale by 1 point or in MMSE by 3 points or neurologic death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Hypofractionated Versus Single Fraction Stereotactic Adjuvant Radiotherapy to the Resection Cavity of Brain Metastases	NCT05160818	Brain Metastase... Resection Cavit...	Hypofractionate...	18 Years -	Technical University of Munich
Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection	NCT01535209	Brain Metastase...	stereotactic bo... Whole-Brain Rad...	18 Years -	Maria Sklodowska-Curie National Research Institute of Oncology

Spots Global Cancer Trial Database for resection cavity