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

Primary Purpose

Brain Metastases, Resection Cavity

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring Brain Metastases, Resection Cavity, Radiotherapy, Stereotactic Irradiation, Gamma Knife

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. Radiation OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm A: HSFRT

Arm B: SRS

Arm Description

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

Outcomes

Primary Outcome Measures

Local control
Local control at the resected site(s)

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2021
Last Updated
December 6, 2021
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT05160818
Brief Title
Hypofractionated Versus Single Fraction Stereotactic Adjuvant Radiotherapy to the Resection Cavity of Brain Metastases
Acronym
SATURNUS
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases, Resection Cavity
Keywords
Brain Metastases, Resection Cavity, Radiotherapy, Stereotactic Irradiation, Gamma Knife

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 Parallel Assignment
Masking
None (Open Label)
Masking Description
The affiliation to the treatment arm will not be blinded to anyone except the study neuroradiologist.
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: HSFRT
Arm Type
Active Comparator
Arm Description
Hypofractionated stereotactic radiotherapy to the resection cavity, dose prescription: 6-7 x 5 Gy
Arm Title
Arm B: SRS
Arm Type
Active Comparator
Arm Description
Single fraction stereotactic radiotherapy to the resection cavity, dose prescription: 1 x 12-20 Gy
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)
Intervention Description
intervention description see above
Primary Outcome Measure Information:
Title
Local control
Description
Local control at the resected site(s)
Time Frame
12 months after adjuvant radiotherapy
Secondary Outcome Measure Information:
Title
LC
Description
Local control at all treated site(s)
Time Frame
12 months after adjuvant radiotherapy
Title
LRC
Description
Locoregional control=CNS progression free survival
Time Frame
12 months after adjuvant radiotherapy
Title
OS
Description
Overall survival
Time Frame
12 months after adjuvant radiotherapy
Title
Salvage-free survival
Description
Overall survival
Time Frame
12 months after adjuvant radiotherapy
Title
Intracranial salvage therapy
Description
Number and kind of intracranial salvage treatments
Time Frame
12 months after adjuvant radiotherapy
Title
Pseudoprogression
Description
Rate of pseudoprogression
Time Frame
up to 12 months after adjuvant radiotherapy
Title
Irradiation-related toxicity
Description
according to CTCAE v4.03, especially rate of radionecrosis
Time Frame
up to 12 months after adjuvant radiotherapy
Title
QoL
Description
Quality of life according to EORTC QLQ-C30 and EORTC QLQ-B20
Time Frame
up to 12 months after adjuvant radiotherapy
Title
Time to loss of independence
Description
defined as decrease in Barthel index by > 20 points
Time Frame
up to 12 months after adjuvant radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Waltenberger
Phone
+49-89-4140-8281
Email
maria.waltenberger@mri.tum.de
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie E Combs, Prof. Dr.
Phone
+49-89-4140-4501
Email
direktion.radonk@mri.tum.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Waltenberger
Organizational Affiliation
Technical University Munich, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Dept. Radiation Oncology
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie E. Combs, Prof. Dr.
Phone
089 4140 4501
Email
direktion.radonk@mri.tum.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26964777
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.
Results Reference
background
PubMed Identifier
31563407
Citation
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.
Results Reference
background

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

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