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

NCT05160818 | Unknown

• 1 other identifier: RadOnc MRI TUM - 2
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases; Resection Cavity

Keywords

Brain Metastases; Resection Cavity; Radiotherapy; Stereotactic Irradiation; Gamma Knife

Outcome Measures

Primary Outcomes (1)

• Local control

  Local control at the resected site(s)

  12 months after adjuvant radiotherapy

Secondary Outcomes (9)

• LC

  12 months after adjuvant radiotherapy

• LRC

  12 months after adjuvant radiotherapy

• OS

  12 months after adjuvant radiotherapy

• Salvage-free survival

  12 months after adjuvant radiotherapy

• Intracranial salvage therapy

  12 months after adjuvant radiotherapy

Study Arms (2)

Arm A: HSFRT

ACTIVE COMPARATOR

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

Radiation: Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)

Arm B: SRS

ACTIVE COMPARATOR

Single fraction stereotactic radiotherapy to the resection cavity, dose prescription: 1 x 12-20 Gy

Radiation: Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS)

Interventions

Hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiotherapy radiosurgery (SRS) RADIATION

intervention description see above

Arm A: HSFRT; Arm B: SRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed solid tumor disease
• One to three resected brain metastases
• Consent to perform adjuvant irradiation by an interdisciplinary tumor board
• Completed wound healing
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Dept. Radiation Oncology

Munich, Bavaria, 81675, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 26964777 BACKGROUND

• 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.

  PMID: 31563407 BACKGROUND

• Waltenberger M, Bernhardt D, Diehl C, Gempt J, Meyer B, Straube C, Wiestler B, Wilkens JJ, Zimmer C, Combs SE. 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. 2023 Jul 29;23(1):709. doi: 10.1186/s12885-023-11202-9.

  PMID: 37516835 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Maria Waltenberger

  Technical University Munich, Germany

  STUDY DIRECTOR

Central Study Contacts

Maria Waltenberger

CONTACT

+49-89-4140-8281; maria.waltenberger@mri.tum.de

Stephanie E Combs, Prof. Dr.

CONTACT

+49-89-4140-4501; direktion.radonk@mri.tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The affiliation to the treatment arm will not be blinded to anyone except the study neuroradiologist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med. Stephanie E. Combs

Model Details: 1:1 Parallel Assignment

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 16, 2021
• Study Start: February 1, 2021
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)