Brain MetastasesRadcavNCT05871307
Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases
A study testing Preoperative Radiotherapy, Intraoperative Radiation and Postoperative Radiotherapy in people with Brain Metastases and Radiotherapy, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Radiotherapy
- What is being tested?
- Preoperative Radiotherapy, Intraoperative Radiation and Postoperative Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2024to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- Contraindication for contrast-enhanced MRI
- Pregnant or lactating women
- Participation in another competing clinical study or observation period of competing trials, respectively
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Radiotherapy, University of Heidelberg
Heidelberg, 69120
About this study
Official title: Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases - A Prospective Randomized Explorative Phase II Trial
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.
Read the 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?
- Conditions
- Brain Metastases, Radiotherapy
- Being tested
- Preoperative Radiotherapy, Intraoperative Radiation, Postoperative Radiotherapy
- Keywords
- Brain Metastases, Radiotherapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative RadiotherapyRadiation
Resection of brain mestases following
Intraoperative RadiationRadiation
While Resection
Postoperative RadiotherapyRadiation
After resection
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm A (Preoperativ SRS) | Experimental | Preoperative stereotatic radiosurgery following resection of brain metastases after 1-7 days Receives: Radiation: Preoperative Radiotherapy |
| Experimental Arm B (Intraoperativ SRS) | Experimental | Intraoperative stereotactic radiotherapy after resection of brain metastases Receives: Radiation: Intraoperative Radiation |
| Standard Treatment Arm C (Posoperativ SRS) | Active comparator | Resection of brain metastases following stereotactic radiotherapy after 2-6 weeks Receives: Radiation: Postoperative Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of treatment response
number of patients without progresion according to RANO-BM
Measured: 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
Measured: through study completion, an avarage of 60 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Feb 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
- Investigators
- Laila König, Prof. Dr., Principal investigator, University Hospital of Heidelberg, Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871307
- Sponsor's protocol ID
- RADOnk-Radcav
- Acronym
- Radcav
- Status last verified
- May 2026
- First submitted
- 2 Nov 2022
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases - A Prospective Randomized Explorative Phase II Trial
- ClinicalTrials.gov ID
- NCT05871307
- Acronym / sponsor ID
- Radcav / RADOnk-Radcav
- Conditions
- Brain Metastases, Radiotherapy
- Keywords
- Brain Metastases, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm A (Preoperativ SRS) | Experimental | Radiation: Preoperative RadiotherapyPreoperative stereotatic radiosurgery following resection of brain metastases after 1-7 days |
| Experimental Arm B (Intraoperativ SRS) | Experimental | Radiation: Intraoperative RadiationIntraoperative stereotactic radiotherapy after resection of brain metastases |
| Standard Treatment Arm C (Posoperativ SRS) | Active comparator | Radiation: Postoperative RadiotherapyResection of brain metastases following stereotactic radiotherapy after 2-6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed solid malignancy
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative RadiotherapyResection of brain mestases following | Radiation | Experimental Arm A (Preoperativ SRS) |
| Intraoperative RadiationWhile Resection | Radiation | Experimental Arm B (Intraoperativ SRS) |
| Postoperative RadiotherapyAfter resection | Radiation | Standard Treatment Arm C (Posoperativ SRS) |
Primary outcome
Assessment of treatment response
Time frame: through study completion, an avarage of 60 month
number of patients without progresion according to RANO-BM
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laila König, Prof. Dr. principal investigator
University Hospital of Heidelberg, Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Radiotherapy, Intraoperative Radiation and Postoperative Radiotherapy in people with Brain Metastases and Radiotherapy, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of treatment response (time frame: through study completion, an avarage of 60 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.