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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05160818

Studienbeginn:
Februar 2021

Letztes Update:
16.12.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasm Metastasis, Brain Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Technical University of Munich

Collaborator:
-

Studienleiter

Maria Waltenberger
Study Director
Technical University Munich, Germany

Kontakt

Maria Waltenberger
Kontakt:
Phone: +49-89-4140-8281
E-Mail: maria.waltenberger@mri.tum.de» Kontaktdaten anzeigen

Stephanie E Combs, Prof. Dr.
Kontakt:
Phone: +49-89-4140-4501
E-Mail: direktion.radonk@mri.tum.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Dept. Radiation Oncology
81675 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Stephanie E. Combs, Prof. Dr.
Phone: 089 4140 4501
E-Mail: direktion.radonk@mri.tum.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Local control (Time Frame - 12 months after adjuvant radiotherapy):
Local control at the resected site(s)

Secondary outcome:

1. LC (Time Frame - 12 months after adjuvant radiotherapy):
Local control at all treated site(s)

2. LRC (Time Frame - 12 months after adjuvant radiotherapy):
Locoregional control=CNS progression free survival

3. OS (Time Frame - 12 months after adjuvant radiotherapy):
Overall survival

4. Salvage-free survival (Time Frame - 12 months after adjuvant radiotherapy):
Overall survival

5. Intracranial salvage therapy (Time Frame - 12 months after adjuvant radiotherapy):
Number and kind of intracranial salvage treatments

6. Pseudoprogression (Time Frame - up to 12 months after adjuvant radiotherapy):
Rate of pseudoprogression

7. Irradiation-related toxicity (Time Frame - up to 12 months after adjuvant radiotherapy):
according to CTCAE v4.03, especially rate of radionecrosis

8. QoL (Time Frame - up to 12 months after adjuvant radiotherapy):
Quality of life according to EORTC QLQ-C30 and EORTC QLQ-B20

9. Time to loss of independence (Time Frame - up to 12 months after adjuvant radiotherapy):
defined as decrease in Barthel index by > 20 points

Studien-Arme

Active Comparator: Arm A: HSFRT
Hypofractionated stereotactic radiotherapy to the resection cavity, dose prescription: 6-7 x 5 Gy
Active Comparator: Arm B: SRS
Single fraction stereotactic radiotherapy to the resection cavity, dose prescription: 1 x 12-20 Gy

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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