Clinical trial · Interventional
Re-TREAT: Re-irradiation for Relapsed Brain Metastases
Re-TREAT: A Phase 2 Study of Stereotactic Re-irradiation of Relapsed Brain Metastases
- 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)
The Re-TREAT study is a prospective clinical, phase 2, interventional, single-arm, multicenter trial for patients with local relapse of one or more brain metastases. Patients with recurrence of one or more brain metastases that have previously been treated with stereotactic radiosurgey (SRS) are treated with repeated SRS. The aim is to evaluate the efficacy and toxicity of salvage SRS. The primary outcome is local control of the relapsed tumor and the secondary endpoints include toxicity as evaluated by the investigator and quality of life measured as a patient reported outcome. As an exploratory endpoint, the value of advanced MRI (magnetic resonance imaging) and PET (positron emission tomography) imaging as a biomarker for prediction of response to treatment or toxicity will be studied.
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, Adult | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Repeated stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- Treatment with stereotactic radiosurgery
- interventionNames
- Radiation: Repeated stereotactic radiosurgery
Primary outcomes (1)
- measure
- Freedom from progression of treated metastasis
- timeFrame
- 3 months post treatment
- description
- Freedom from progression of lesion size defined as stable or decreasing unidimensional measurement (longest diameter) on T1-weighted contrast enhanced magnetic resonance imaging (MRI)
Secondary outcomes (6)
- measure
- Adverse events
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Brain metastases of solid tumor (carcinoma of unknown origin may be included but histological verification in case of BM alone is required) * Progression of previously treated lesion as decided by the multidisciplinary team conference * Previous single fraction SRS in area in question and dose plans must be available electronically * Previous single fraction SRS given \> 3 months previously * ECOG (Eastern Cooperative Oncology Group) performance status ≤2 * Life expectancy \>3 months * Signed written consent. * Patients may have more than one recurring lesion and may also have new, untreated metastases which may be treated with standard SRS (up to a total of 4 metastases in accordance with Danish national guidelines). Exclusion Criteria: * Two previous courses of radiotherapy for the same metastasis (e.g. SRS and WBRT) * Target lesions located in- or in proximity to eloquent brain areas that require reduction of radiotherapy dose * Target lesion gross tumor volume (GTV) for radiotherapy greater than 14,1 cm3 (equivalent to a sphere with a diameter of 3 cm) * Current or planned concomitant medical treatment that is likely to be active against brain metastases (e.g. tyrosine kinase inhibitors for EGFR-positive (epidermal growth factor receptor) non-small cell lung cancer) or that may influence interpretation of images (e.g. bevacizumab, a monoclonal antibody directed towards VEGF (vascular endothelial growth factor)) in the opinion of the investigators * Contraindication to magnetic resonance imaging using Gadolinium contrast enhancement (e.g. pacemaker, metallic implant or impaired renal function) * Rapid extracranial disease progression that in the opinion of the investigators confer a high risk of drop out from the study without evaluation scan at 3 months
References
Publications (0)
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