University Hospital Heidelberg
Juergen Debus
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.
Brain Metastases
Radiotherapy
Preoperative Radiotherapy
Intraoperative Radiation
Postoperative Radiotherapy
Phase 2
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 Type : | Interventional |
| Estimated Enrollment : | 90 participants |
| 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 |
| Actual Study Start Date : | February 1, 2024 |
| Estimated Primary Completion Date : | May 1, 2026 |
| Estimated Study Completion Date : | May 1, 2028 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Experimental Arm A (Preoperativ SRS) Preoperative stereotatic radiosurgery following resection of brain metastases after 1-7 days |
Radiation: Preoperative Radiotherapy |
|
Experimental: Experimental Arm B (Intraoperativ SRS) Intraoperative stereotactic radiotherapy after resection of brain metastases |
Radiation: Intraoperative Radiation |
|
Active Comparator: Standard Treatment Arm C (Posoperativ SRS) Resection of brain metastases following stereotactic radiotherapy after 2-6 weeks |
Radiation: Postoperative Radiotherapy |
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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Not yet recruiting
Department of Radiotherapy, University of Heidelberg
Heidelberg, Germany, 69120