Comparing different timing of radiotherapy for brain metastases treatment
Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases - A Prospective Randomized Explorative Phase II Trial
NA · University Hospital Heidelberg · NCT05871307
This study is testing three different timing methods of radiotherapy for patients with brain metastases to see which one works best for treatment and recovery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg (other) |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT05871307 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of three different approaches to radiotherapy for patients with resectable brain metastases: neoadjuvant, intraoperative, and adjuvant stereotactic radiotherapy. By comparing these methods, the study aims to analyze the differences in immune profiling, dosimetry, efficacy, and toxicity through detailed examination of resected tissue samples, cerebrospinal fluid, and blood. The goal is to understand how timing and method of radiotherapy impact tumor response and patient outcomes. This phase 2 trial will provide insights into the optimal treatment strategy for improving the management of brain metastases.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed solid malignancies and 1-10 brain metastases, specifically those with a maximum size of 5cm and suitable for both surgery and stereotactic radiotherapy.
Not a fit: Patients with brain metastases located in eloquent areas of the brain or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for brain metastases, enhancing patient survival and quality of life.
How similar studies have performed: While there have been studies on radiotherapy for brain metastases, this direct comparison of timing and method is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Heidelberg
- Department of Radiotherapy, University of Heidelberg — Heidelberg, Germany (RECRUITING)
Study contacts
- Principal investigator: Jürgen Debus, Prof. — University Hospital of Heidelberg, Radiation Oncology
- Study coordinator: Tanja Eichkorn, MD
- Email: tanja.eichkorn@med.uni-heidelbeg.de
- Phone: 06221 56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Metastases, Radiotherapy