Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05871307

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Department of Radiotherapy, University of Heidelberg

Heidelberg, Germany, 69120

Actively Recruiting

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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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