A Study to Assess the Efficacy of Cerebellar IMRT Combined With Cerebral SRS in Patients With Brain Metastases
- Conditions
- Brain MetastasesPosterior Fossa LesionCerebral Lesion
- Interventions
- Radiation: Radiation treatment
- Registration Number
- NCT05477316
- Lead Sponsor
- Hadassah Medical Organization
- Brief Summary
A single-arm pilot study, to assess the efficacy of cerebellar IMRT combined with cerebral SRS in patients with brain metastases that are predominantly in the posterior fossa - a novel treatment approach
- Detailed Description
This study includes patients with brain metastases, presenting with more than 5 cerebellar lesions and less than 10 cerebral lesions. This is a pilot study assessing the efficacy of a novel, combined treatment approach involving Intensity-modulated Radiation Therapy (IMRT)/ Volumetric Modulated Arc Therapy (VMAT), with or without integrated boost to metastases, administered to the posterior fossa, and Stereotactic Radiosurgery (SRS) administered to cerebral lesions. This is opposed to the current recommended treatment approach for such cases, being whole brain radiotherapy (WBRT). While an effective treatment with respect to lesion control, WBRT is not ideal as the total deliverable dose is limited to 30 Gy due to toxicity. In addition, this technique is responsible for major side effects, especially neurocognitive deterioration.
There are select cases of multiple brain metastases which are predominantly found in the posterior fossa. Rectal cancer is one such notorious example, however this type of spread is not limited to one region.
The investigators hypothesize that utilizing the novel combinational treatment approach of IMRT and SRS in cerebral and cerebellar brain metastases will improve long term brain control, maintain the patients' cognitive function and potentially improve overall survival, as the need for potent WBRT will become obsolete.
Patients with multiple brain metastases present in the cerebrum and cerebellum will be treated with SRS and IMRT respectively, simultaneously (within 3 weeks of one another). Brain MRI scans will be performed before commencement of the novel treatment approach, at two month after RT, and then every 3 months, or as indicated clinically, after treatment start. Concurrently at each MRI scan time point, patients will be assessed based on brain and whole-body metastatic progression by RECIST. Patients will also be assessed for central nervous system (CNS) - progression free survival (PFS) and body-PFS, cognitive function, quality of life and overall survival status via standardized follow-up tests.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Radiation treatment Intensity-modulated Radiation Therapy (IMRT)/VMAT with integrated boost to the cerebellum and metastases and Stereotactic Radiosurgery (SRS) to the cerebral metastases as a novel treatment combination for brain metastases
- Primary Outcome Measures
Name Time Method Brain control: Central Nervous System (CNS)- Progression Free Survival (PFS) Change in lesion size in the whole body will be followed and assessed at screen, 2 month after radiation treatment, then every 3 month until the date of first documented progression or date of death from any cause, up to 10 years. Metastatic brain lesions treated with IMRT/SRS will be tracked and measured using MRI. Disease in the brain and systemically will be assessed by RECIST.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Status will be checked at every visit and follow up, until the date of death from any cause, up to 10 years. Patient OS will be assessed via timely patient follow-ups on survival status
Cognitive function Change in patient cognitive function will be followed and assessed at screen, 2 month after radiation treatment, then every 3 month, until the date of first documented progression or date of death from any cause, up to 10 years. Patient cognitive function will improve after study treatment (Hopkines verbal learning test (HVLT), Trail Making Test (TMT) A + B, Controlled Oral Word Association Test (COWAT) and clock drawing test). Cognitive functions will be univariately compared between the groups using the Student's t-test or the Mann-Whitney Ranks test. We will also perform multivariate analyses using either linear regression of Poisson regression, depending on the outcomes distribution.
Quality of life (QOL) Change in patient QOL will be followed and assessed at screen, 2 month after radiation treatment, then every 3 month, until the date of first documented progression or date of death from any cause, up to 10 years. Patient QOL will improve after study treatment. QOL will be evaluated due to score in four questionnaires: European Organisation for. Research and Treatment of Cancer (EORTC) QLQ C30, The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT), The Pittsburgh Sleep Quality Index (PSQI) and Hospital Anxiety and Depression Scale (HADS). Cognitive functions will be univariately compared between the groups using the Student's t-test or the Mann-Whitney Ranks test. We will also perform multivariate analyses using either linear regression of Poisson regression, depending on the outcomes distribution.
Trial Locations
- Locations (1)
Hadassah Ein Kerem Medical Center
🇮🇱Jerusalem, Israel