Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases

NCT05871307 | Recruiting

• 1 other identifier: RADOnk-Radcav
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Brain Metastases; Radiotherapy

Keywords

Brain Metastases; Radiotherapy

Outcome Measures

Primary Outcomes (2)

• Assessment of treatment response

  number of patients without progresion according to RANO-BM

  through study completion, an avarage of 60 month

• local tumor control

  events of tumor progression or recurrence in the area of 1cm surrounding the resection cavity and surrounding the surgical access

  through study completion, an avarage of 60 month

Study Arms (3)

Experimental Arm A (Preoperativ SRS)

EXPERIMENTAL

Preoperative stereotatic radiosurgery following resection of brain metastases after 1-7 days

Radiation: Preoperative Radiotherapy

Experimental Arm B (Intraoperativ SRS)

EXPERIMENTAL

Intraoperative stereotactic radiotherapy after resection of brain metastases

Radiation: Intraoperative Radiation

Standard Treatment Arm C (Posoperativ SRS)

ACTIVE COMPARATOR

Resection of brain metastases following stereotactic radiotherapy after 2-6 weeks

Radiation: Postoperative Radiotherapy

Interventions

Preoperative Radiotherapy RADIATION

Resection of brain mestases following

Experimental Arm A (Preoperativ SRS)

Intraoperative Radiation RADIATION

While Resection

Experimental Arm B (Intraoperativ SRS)

Postoperative Radiotherapy RADIATION

After resection

Standard Treatment Arm C (Posoperativ 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 malignancy
• Metastatic brain disease (1-10 brain metastases), with at least one brain metastasis in a non-eloquent location (i.e. motor or speech) planned for resection
• Maximum size of the brain metastasis \<5cm
• Eligibility of patients for both stereotactic radiotherapy and resection
• Time interval from resection to adjuvant stereotactic radiosurgery of 2-6 weeks
• Time interval from neoadjuvant stereotactic radiosurgery to resection of 1-7 days
• Possibility to postpone resection for neoadjuvant stereotactic radiosurgery, if applicable
• Karnofsky performance scores \>= 70 or Eastern Cooperative Oncology Group (ECOG) \>= 2 at enrollment
• Age ≥ 18 years of age
• For women with childbearing potential, (and men) adequate contraception.
• Ability of subject to understand character and individual consequences of the clinical trial
• Written informed consent (must be available before enrolment in the trial)

You may not qualify if:

• Necessity of immediate surgical resection due to life threatening symptoms
• brain metastasis directly located (≤10mm) next to the optic system or brain stem
• Refusal of the patients to take part in the study
• Small-cell lung cancer (SCLC) or hematologic malignancy as primary malignant illness
• Leptomeningeal disease suspected RadCav Trial Protocol Version 1.1, 01.07.2022 18
• Previous radiotherapy of the brain
• Contraindication for contrast-enhanced MRI
• Pregnant or lactating women
• Participation in another competing clinical study or observation period of competing trials, respectively

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

Department of Radiotherapy, University of Heidelberg

Heidelberg, 69120, Germany

RECRUITING

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

• Jürgen Debus, Prof.

  University Hospital of Heidelberg, Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanja Eichkorn, MD

CONTACT

06221 56; tanja.eichkorn@med.uni-heidelbeg.de

Adriane Hommertgen, PhD

CONTACT

06221 56; adriane.hommertgen@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Director

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: May 23, 2023
• Study Start: February 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)