Actively Recruiting
Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases
Led by University Hospital Heidelberg · Updated on 2026-05-05
90
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients suffering from malignancies in advanced stages often develop brain metastases, which limit both the life span and the quality of life. Combining surgery and radiotherapy for resectable brain metastases is standard of care but there is a lot of controversy on which kind of radiotherapy is best suitable. Recently, first volumetric in-silico analyses point to theoretical advantages of neoadjuvant stereotactic radiotherapy of brain metastases. Special about this trial is the direct comparison between the three currently discussed radiotherapy options for resectable brain metastases: Neoadjuvant stereotactic radiotherapy, intraoperative radiotherapy and adjuvant stereotactic radiotherapy.
CONDITIONS
Official Title
Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed solid malignancy
- 1 to 10 brain metastases with at least one in a non-eloquent brain area planned for resection
- Maximum brain metastasis size less than 5 cm
- Eligible for both stereotactic radiotherapy and surgical resection
- Time from resection to adjuvant stereotactic radiosurgery between 2 and 6 weeks
- Time from neoadjuvant stereotactic radiosurgery to resection between 1 and 7 days
- Ability to postpone surgery for neoadjuvant radiotherapy if needed
- Karnofsky performance score of 70 or higher, or ECOG score of 2 or less at enrollment
- Age 18 years or older
- Adequate contraception for women of childbearing potential and men
- Ability to understand the trial and provide written informed consent
You will not qualify if you...
- Need for immediate surgery due to life-threatening symptoms
- Brain metastasis located within 10 mm of the optic system or brain stem
- Patient refusal to participate
- Primary diagnosis of small-cell lung cancer or hematologic malignancy
- Suspected leptomeningeal disease
- Previous radiotherapy to the brain
- Contraindication for contrast-enhanced MRI
- Pregnant or breastfeeding women
- Participation in another competing clinical trial or observation period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Radiotherapy, University of Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
Research Team
T
Tanja Eichkorn, MD
CONTACT
A
Adriane Hommertgen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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