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Trial Title:
Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases
NCT ID:
NCT05871307
Condition:
Brain Metastases
Radiotherapy
Conditions: Official terms:
Neoplasm Metastasis
Brain Neoplasms
Conditions: Keywords:
Brain Metastases
Radiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Preoperative Radiotherapy
Description:
Resection of brain mestases following
Arm group label:
Experimental Arm A (Preoperativ SRS)
Intervention type:
Radiation
Intervention name:
Intraoperative Radiation
Description:
While Resection
Arm group label:
Experimental Arm B (Intraoperativ SRS)
Intervention type:
Radiation
Intervention name:
Postoperative Radiotherapy
Description:
After resection
Arm group label:
Standard Treatment Arm C (Posoperativ SRS)
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.
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?
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Radiotherapy, University of Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Juergen Debus, Prof. Dr. Dr.
Phone:
+49 6221 56
Phone ext:
8200
Email:
juergen.debus@med.uni-heidelberg.de
Contact backup:
Last name:
Adriane Hommertgen, Dr. med.
Phone:
0622156
Phone ext:
34091
Email:
adriane.hommertgen@med.uni-heidelberg.de
Start date:
February 1, 2024
Completion date:
May 1, 2028
Lead sponsor:
Agency:
University Hospital Heidelberg
Agency class:
Other
Source:
University Hospital Heidelberg
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05871307
