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Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases (Radcav)

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ClinicalTrials.gov Identifier: NCT05871307
Recruitment Status : Not yet recruiting
First Posted : May 23, 2023
Last Update Posted : January 5, 2024
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Study Description
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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.


Condition or disease Intervention/treatment Phase
Brain Metastases Radiotherapy Radiation: Preoperative Radiotherapy Radiation: Intraoperative Radiation Radiation: Postoperative Radiotherapy Phase 2

Detailed Description:
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?
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases - A Prospective Randomized Explorative Phase II Trial
Estimated Study Start Date : February 1, 2024
Estimated Primary Completion Date : May 1, 2026
Estimated Study Completion Date : May 1, 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Arm A (Preoperativ SRS)
Preoperative stereotatic radiosurgery following resection of brain metastases after 1-7 days
 Radiation: Preoperative Radiotherapy
Resection of brain mestases following
Experimental: Experimental Arm B (Intraoperativ SRS)
Intraoperative stereotactic radiotherapy after resection of brain metastases
 Radiation: Intraoperative Radiation
While Resection
Active Comparator: Standard Treatment Arm C (Posoperativ SRS)
Resection of brain metastases following stereotactic radiotherapy after 2-6 weeks
 Radiation: Postoperative Radiotherapy
After resection


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05871307


Contacts
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Contact: Tanja Eichkorn, MD 06221 56 ext 8201 tanja.eichkorn@med.uni-heidelbeg.de
Contact: Adriane Hommertgen, PhD 06221 56 ext 34091 adriane.hommertgen@med.uni-heidelberg.de

Locations
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Germany
Department of Radiotherapy, University of Heidelberg
Heidelberg, Germany, 69120
Contact: Juergen Debus, Prof. Dr. Dr.    +49 6221 56 ext 8200    juergen.debus@med.uni-heidelberg.de   
Contact: Adriane Hommertgen, Dr. med.    0622156 ext 34091    adriane.hommertgen@med.uni-heidelberg.de   
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
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Principal Investigator: Jürgen Debus, Prof. University Hospital of Heidelberg, Radiation Oncology
More Information
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Responsible Party: Juergen Debus, Department Director, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT05871307    
Other Study ID Numbers: RADOnk-Radcav
First Posted: May 23, 2023    Key Record Dates
Last Update Posted: January 5, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juergen Debus, University Hospital Heidelberg:
Brain Metastases
Radiotherapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
 Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases