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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05160818
Other study ID # RadOnc MRI TUM - 2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date August 1, 2025

Study information

Verified date December 2021
Source Technische Universität München
Contact Maria Waltenberger
Phone +49-89-4140-8281
Email maria.waltenberger@mri.tum.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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) - 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: - 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

Study Design


Intervention

Radiation:
Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)
intervention description see above

Locations

Country Name City State
Germany Dept. Radiation Oncology Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Local control Local control at the resected site(s) 12 months after adjuvant radiotherapy
Secondary LC Local control at all treated site(s) 12 months after adjuvant radiotherapy
Secondary LRC Locoregional control=CNS progression free survival 12 months after adjuvant radiotherapy
Secondary OS Overall survival 12 months after adjuvant radiotherapy
Secondary Salvage-free survival Overall survival 12 months after adjuvant radiotherapy
Secondary Intracranial salvage therapy Number and kind of intracranial salvage treatments 12 months after adjuvant radiotherapy
Secondary Pseudoprogression Rate of pseudoprogression up to 12 months after adjuvant radiotherapy
Secondary Irradiation-related toxicity according to CTCAE v4.03, especially rate of radionecrosis up to 12 months after adjuvant radiotherapy
Secondary QoL Quality of life according to EORTC QLQ-C30 and EORTC QLQ-B20 up to 12 months after adjuvant radiotherapy
Secondary Time to loss of independence defined as decrease in Barthel index by > 20 points up to 12 months after adjuvant radiotherapy
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