Clinical trial · Interventional
Perfexion Brain Metastasis
Hypofractionated Stereotactic Radiotherapy (HF-SRT) for Large-Volume 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)
Brain metastases occur in 20% to 40% of all patients with cancer , with an incidence 10 times higher than that of primary malignant brain tumors. Patients with brain metastases have a poor prognosis with a median survival of 1-2 months with corticosteroids and 5-7 months with whole brain radiotherapy (WBRT). Local control achieved with WBRT in patients with otherwise controlled systemic disease remains at issue. A single high dose of radiation delivered with high precision to the target lesion (Stereotactic radiosurgery (SRS)), is considered standard care in salvage of recurrent lesions after WBRT. SRS can destroy tumour with very little damage to surrounding tissue. Research suggests that delivering radiotherapy in a number of smaller doses is more beneficial than receiving all of the radiotherapy in a single dose. Brain metastases are well suited for SRS as they are often small, radiographically well-circumscribed, pseudospherical tumors that are noninfiltrative.
Conditions
Conditions (1)
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 | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated stereotactic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- (HFA-SRT) in Large-Volume Brain Metastases
- interventionNames
- Radiation: Hypofractionated stereotactic radiotherapy
Primary outcomes (1)
- measure
- This study aims to determine what the maximum tolerated dose of hypofractionated adaptive stereotactic radiotherapy (HFA-SRT) for recurrent brain metastases is.
- timeFrame
- every 3 months for 3 years
Secondary outcomes (2)
- measure
- The secondary outcome will be to evaluate the overall survival and change in tumour response.
- timeFrame
- every 3 months for 3 years
- measure
- Measure acute and late toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1-5 recurrent brain metastases after WBRT, and * At least 1 lesions \>2cm in maximum diameter * ECOG 0-2 * Life expectancy \>3months * Age ≥ 18 years old Exclusion Criteria: * Edentulous patients * Prior surgery or injury to hard palate * Severe claustrophobia * Contraindication to MRI * Contraindication to IV contrast (Gadolinium) administration * Other medical conditions that would preclude study investigations * Prior radiosurgery to recurrent lesions * Radiation cannot be delivered at the assigned dose level in a manner that respects OAR constraints (3.2.2.4.2.3.4) (e.g. lesions within brainstem or abutting optic structures) * Any lesion \>5cm in diameter, or total volume of tumor \> 60cc * Pregnant Women * Men or women of childbearing potential who are unwilling to employ adequate contraception
References
Publications (0)
Data not yet available