Clinical trial · Interventional
Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases
Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases - A Prospective Randomized Explorative Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative Radiation | Radiation | — | UNRESOLVED |
| Postoperative Radiotherapy | Radiation | — | UNRESOLVED |
| Preoperative Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Experimental Arm A (Preoperativ SRS)
- description
- Preoperative stereotatic radiosurgery following resection of brain metastases after 1-7 days
- interventionNames
- Radiation: Preoperative Radiotherapy
- type
- EXPERIMENTAL
- label
- Experimental Arm B (Intraoperativ SRS)
- description
- Intraoperative stereotactic radiotherapy after resection of brain metastases
- interventionNames
- Radiation: Intraoperative Radiation
- type
- ACTIVE_COMPARATOR
- label
- Standard Treatment Arm C (Posoperativ SRS)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available