NTS-WBRT vs. HA-WBRT for Brain Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Massachusetts General Hospital
Must not be taking: NMDA antagonists
Disqualifiers: Leptomeningeal disease, Prior WBRT, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This research is being done to assess the quality of life and symptom burden in participants who receive (normal tissue sparing whole brain radiation therapy (NTS-WBRT).
This research study involves:
* NTS-WBRT (normal tissue sparing whole brain radiation therapy)
* Memantine standard of care drug
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it allows any prior, concurrent, or post-radiotherapy systemic therapy at the discretion of your treating physician. You cannot participate if you are currently using memantine or other NMDA antagonists.
What data supports the effectiveness of the treatment HA-WBRT for brain cancer?
Research indicates that HA-WBRT (Hippocampal-Avoidant Whole Brain Radiotherapy) can help preserve cognitive function better than traditional whole brain radiotherapy by avoiding damage to the hippocampus, a part of the brain important for memory. Studies also suggest that HA-WBRT may prevent cognitive decline and improve outcomes for patients with brain metastases.
12345Is HA-WBRT safe for humans?
HA-WBRT (Hippocampal-Avoidant Whole Brain Radiotherapy) is generally considered safe and may help preserve cognitive function better than traditional whole brain radiotherapy. Studies suggest it can reduce treatment-related cognitive decline, which is a common concern with brain radiation treatments.
12356What makes the NTS-WBRT and HA-WBRT treatments unique for brain cancer?
NTS-WBRT and HA-WBRT are unique because they aim to spare healthy brain tissue, particularly the hippocampus, which is important for memory, during whole brain radiation therapy. This approach is designed to reduce cognitive side effects compared to traditional whole brain radiation therapy.
7891011Eligibility Criteria
Adults with brain metastases from solid tumors, who can have an MRI and are expected to live more than 6 months. They should be able to perform daily activities well (Karnofsky score ≥70), understand English, consent in writing, and return for follow-ups for up to 2 years. Pregnant women or those using certain drugs like memantine are excluded.Inclusion Criteria
My doctor may allow previous targeted brain radiation.
I've had brain radiation, but less than half of my brain was treated, as decided by my doctor.
Ability to return for follow-up examinations throughout the course of this study for a maximum of 2 years after radiation treatment completion
+10 more
Exclusion Criteria
I have been diagnosed with leptomeningeal disease.
I do not have any severe illnesses that could affect my thinking or compliance with the study.
Known allergy to contrast used in imaging studies and/or inability to have MRI imaging
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive NTS-WBRT for 5 days per week for either 2 or 3 weeks, along with Memantine as standard of care
2-3 weeks
5 visits per week (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of quality of life and symptom burden
4 months
Regular follow-up visits at baseline, 2, 4, 6, 9, 12, 18, and 24 months
Long-term follow-up
Participants are monitored for overall survival and other secondary outcomes
Up to 24 months
Participant Groups
The trial compares two radiation therapies: NTS-WBRT which spares normal tissue, and HA-WBRT that avoids the hippocampus area of the brain. Both groups will also receive Memantine. The goal is to see which treatment better maintains quality of life.
1Treatment groups
Experimental Treatment
Group I: NTS-WBRT (normal tissue sparing whole brain radiation therapy) + MemantineExperimental Treatment2 Interventions
Participants will be randomly assigned to NTS-WBRT (normal tissue sparing whole brain radiation therapy) administration group and receive:
* NTS-WBRT for 5 days (Monday-Friday) for either 2 or 3 weeks.
* Memantine per standard of care, 1-2x daily for up to 24 weeks Specific participant administration schedules will be determined by study doctor
HA-WBRT is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Hippocampal-Avoidant Whole Brain Radiotherapy for:
- Brain metastases from small cell lung cancer
- Other brain metastases
🇪🇺 Approved in European Union as Hippocampal-Avoidant Whole Brain Radiotherapy for:
- Brain metastases from various cancers
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General Hospital Cancer CenterBoston, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
References
Hippocampal avoidance whole-brain radiotherapy without memantine in preserving neurocognitive function for brain metastases: a phase II blinded randomized trial. [2021]Hippocampal avoidance whole-brain radiotherapy (HA-WBRT) shows potential for neurocognitive preservation. This study aimed to evaluate whether HA-WBRT or conformal WBRT (C-WBRT) is better for preserving neurocognitive function.
Evaluating the Heterogeneity of Hippocampal Avoidant Whole Brain Radiotherapy Treatment Effect: A Secondary Analysis of NRG CC001. [2023]Hippocampal avoidant whole brain radiotherapy (HA-WBRT) is the standard of care for patients needing WBRT for brain metastases (BM). This study, using existing data from NRG Oncology CC001 including baseline tumor characteristics and patient-reported MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) scores, sought to identify subgroups of patients that demonstrate differential neuroprotective treatment response to HA-WBRT.
Radiological distribution of brain metastases and its implication for the hippocampus avoidance in whole brain radiotherapy approach. [2018]Hippocampus avoidance in whole brain radiotherapy (HA-WBRT) offers the feasibility of less-impaired cognitive function than conventional WBRT. The study aims to assess the radiological distribution of brain metastases (BMs) with relation to the hippocampus and peri-hippocampus region as defined by the RTOG 0933 for better understanding of margin definition in HA-WBRT treatment planning.
Dosimetric evaluation of intensity-modulated radiotherapy, volumetric modulated arc therapy, and helical tomotherapy for hippocampal-avoidance whole brain radiotherapy. [2022]Whole brain radiotherapy (WBRT) is a vital tool in radiation oncology and beyond, but it can result in adverse health effects such as neurocognitive decline. Hippocampal Avoidance WBRT (HA-WBRT) is a strategy that aims to mitigate the neuro-cognitive side effects of whole brain radiotherapy treatment by sparing the hippocampi while delivering the prescribed dose to the rest of the brain. Several competing modalities capable of delivering HA-WBRT, include: Philips Pinnacle step-and-shoot intensity modulated radiotherapy (IMRT), Varian RapidArc volumetric modulated arc therapy (RapidArc), and helical TomoTherapy (TomoTherapy).
Whole brain irradiation with hippocampal sparing and dose escalation on multiple brain metastases: Local tumour control and survival. [2022]Hippocampal-avoidance whole brain radiotherapy (HA-WBRT) for multiple brain metastases may prevent treatment-related cognitive decline, compared to standard WBRT. Additionally, simultaneous integrated boost (SIB) on individual metastases may further improve the outcome. Here, we present initial data concerning local tumour control (LTC), intracranial progression-free survival (PFS), overall survival (OS), toxicity and safety for this new irradiation technique.
Left hippocampus sparing whole brain radiotherapy (WBRT): A planning study. [2022]Unilateral sparing of the dominant (left) hippocampus during whole brain radiotherapy (WBRT) could mitigate cognitive decline, especially verbal memory, similar to the widely investigated bilateral hippocampus avoidance (HA-WBRT). The aim of this planning study is dosimetrical comparison of HA-WBRT with only left hippocampus sparing (LHA-WBRT) plans.
Auditory verbal learning test can lateralize hippocampal sclerosis. [2022]The ability of the Auditory Verbal Learning Test (AVLT) to lateralize hippocampal sclerosis (HS) in mesial temporal lobe epilepsy (MTLE) was explored in a sample of 50 patients with MTLE-HS (23 right and 27 left). Patients' AVLT scores were adjusted to the demographic characteristics of each individual in accordance with the Portuguese normative data. The laterality of the HS was determined by consensus by two neuroradiologists. ROC curves were used to identify the best AVLT cutoff scores to differentiate right vs. left HS. Diagnostic statistics were applied to different AVLT measures. The study results revealed that four AVLT scores can correctly classify the laterality of HS in the total sample and a sub-group of 39 right-handed patients (Edinburgh Laterality Inventory +100): delayed recall trial (76 and 80%, respectively), delayed recognition trial (64 and 67%, respectively), learning over trials index (64 and 74%, respectively), and long-term percent retention index (68 and 72%, respectively). In right-handed patients, the diagnostic capability of the delayed recall trial was improved by pairing it with the learning over trials index (accuracy of 85%). In sum, AVLT measures of verbal memory differentiate left from right HS in MTLE. The delayed recall trial demonstrated good diagnostic capacity.
Developing a comprehensive presurgical functional MRI protocol for patients with intractable temporal lobe epilepsy: a pilot study. [2006]Our aim was to put together and test a comprehensive functional MRI (fMRI) protocol which could compete with the intracarotid amytal (IAT) or Wada test for the localisation of language and memory function in patients with intractable temporal lobe epilepsy. The protocol was designed to be performed in under 1 h on a standard 1.5 tesla imager. We used five paradigms to test nine healthy right-handed subjects: complex scene-encoding, picture-naming, reading, word-generation and semantic-decision tasks. The combination of these tasks generated two activation maps related to memory in the mesial temporal lobes, and three language-related maps of activation in a major part of the known language network. The functional maps from the encoding and naming tasks showed typical and symmetrical posterior mesial temporal lobe activation related to memory in all subjects. Only four of nine subjects also showed symmetrical anterior hippocampal activation. Language lateralisation was best with the word generation and reading paradigms and proved possible in all subjects. The reading paradigm enables localisation of language function in the left anterior temporal pole and middle temporal gyrus, areas typically resected during epilepsy surgery. The combined results of this comprehensive f MRI protocol are adequate for a comparative study with the IAT in patients with epilepsy being assessed for surgery.
Limitations of Wada memory asymmetry as a predictor of outcomes after temporal lobectomy. [2015]The intracarotid amobarbital (Wada) test can be used to evaluate hemispheric memory capacity before anterior temporal lobectomy (ATL). Most patients demonstrate better memory with injection ipsilateral to planned resection (expected asymmetry [EA]), but a substantial minority show better memory with contralateral injection (unexpected asymmetry [UA]). Both degree and direction of Wada memory asymmetry (WMA) have been associated with worse surgical outcome in small series. Reports also suggest that UA is associated with greater decline in verbal memory after left ATL (L-ATL).
Role of the Wada test and functional magnetic resonance imaging in preoperative mapping of language and memory: two atypical cases. [2015]The Wada test is an invasive procedure used to determine cerebral memory and language dominance as well as risk of cognitive deficits following neurosurgery. However, the potential risks of Wada testing have led some to consider foregoing Wada testing in candidates for resective epilepsy surgery with right hemispheric seizure onset. We present two atypical cases in which the Wada test showed unexpected memory and language lateralization. These cases underscore the importance of functional magnetic resonance in which imaging and Wada examination in right-handed individuals even when the lesion would not suggest atypical language representation.
FMRI reveals functional cortex in a case of inconclusive Wada testing. [2013]The intracarotid amobarbital test (Wada test) currently represents the gold standard for preoperative lateralization of hemispheric dominance. Here, we report an epileptic patient with a longstanding extended lesion of the left hemisphere showing absence of motor and speech dysfunction with left carotid amobarbital injection, but tetraplegia and speech arrest with right carotid injection interpreted as a neuroplastic shift of motor and language functions to the right hemisphere. In contrast to the Wada results, motor functional magnetic resonance imaging (fMRI) showed a strong left hemispheric activation with right hand movements.