Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases (NCT05871307) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases
Germany90 participantsStarted 2024-02-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of treatment response
Timeframe: through study completion, an avarage of 60 month
2
local tumor control
Timeframe: through study completion, an avarage of 60 month