Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05871307

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Radiotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Radiotherapy, University of Heidelberg

Heidelberg, 69120, Germany

About this study

This trial approach allows for detailed comparison of resected tissue samples, cerebrospinal fluid and blood of all patient groups. So, the investigators will investigate biomaterial of recently irradiated (neoadjuvant and intraoperative arms) and non-irradiated (adjuvant arm) tissue. All this prompts the main issues of the explorative randomized controlled phase 2 RADCAV trial: Is there a difference between neoadjuvant stereotactic radiotherapy vs. intraoperative radiotherapy vs. adjuvant stereotactic radiotherapy regarding the factors immune profiling, dosimetry, efficacy and toxicity. It can be hypothesized that the resected tissue differs between recently irradiated and non-irradiated brain metastases, for example regarding different histopathologic and molecular pathologic markers including immune environment, markers for cell death and markers for tumor invasion. Are there histopathologic and molecular pathologic markers of tumor cell response and prognosis so the investigators can better understand the effects of irradiation on metastatic brain tissue? And are there relevant differences in dosimetry that put patients at different risks for efficacy and toxicity?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

preoperative radiotherapy

Radiation

Resection of brain mestases following

Intraoperative Radiation

Radiation

While Resection

Postoperative Radiotherapy

Radiation

After resection

Primary outcomes

  1. Assessment of treatment response

    Time frame: through study completion, an avarage of 60 month

    number of patients without progresion according to RANO-BM

  2. local tumor control

    Time frame: through study completion, an avarage of 60 month

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

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Official study title

Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases - A Prospective Randomized Explorative Phase II Trial

Acronym: Radcav

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
May 23, 2023
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.