Clinical trial NCT05013892: NTS-WBRT in Brain Metastases
Official title: Phase II Trial of Normal Tissue Sparing Whole Brain Radiation Therapy (NTS-WBRT) in Patients With Brain Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Brain Metastases
Keywords: Brain Metastases
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: This is a Phase 2 trial testing the safety and effectiveness of NTS-WBRT (normal tissue sparing whole brain radiation therapy) in treating brain metastases.

NTS-WBRT is a targeted radiation therapy that further reduces radiation dose to tissue that does not need radiation therapy treatment.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

It is expected that about 41 people will take part in this research study.

Eligibility criteria: Inclusion Criteria:

* Any patient with a solid tumor diagnosis and any number of brain metastasis clinically indicated for cranial irradiation with whole brain radiation therapy
* Age ≥ 18
* Karnofsky Performance Status ≥ 70
* Prior stereotactic radiosurgery (SRS) permissible per physician discretion
* Prior craniotomy permissible per physician discretion. Protocol radiation therapy should be initiated ≥2 weeks after craniotomy.
* Prior partial brain radiation therapy permissible if target volume \< 50% brain and per physician discretion
* Expectant \> 6 months survival
* Ability to understand and the willingness to sign a written informed consent document.
* Fluency in English, able to complete questionnaires and neurocognitive testing
* Ability to undergo MRI with gadolinium examination
* Ability to return for follow-up examinations throughout the course of this study for a maximum of 2 years after radiation treatment completion
* Any prior, concomitant, or post-radiotherapy systemic therapy is permitted at discretion of treating physicians
* Negative pregnancy test for premenopausal women

Exclusion Criteria:

* Leptomeningeal disease (by any one or more of clinical assessment, radiographic assessment, or cerebrospinal fluid study)
* Prior whole brain radiation therapy
* Pre-existing or current use of memantine or other NMDA antagonists
* Known allergy to contrast used in imaging studies and/or inability to have MRI imaging
* Uncontrolled intercurrent illness that could significantly affect baseline cognitive function as determined by the enrolling clinician, such as symptomatic congestive heart failure, unstable angina pectoris, prior CVA, significant uncontrolled epilepsy or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or unwilling to use appropriate contraception to prevent pregnancy during the time of radiation therapy
* Concurrent participation in an investigational systemic therapy protocol.

Primary outcomes:
measure: Change in Patient Reported Quality of Life for NTS-WBRT (normal tissue sparing whole brain radiation therapy)
timeFrame: 4 Months
measure: Change in Patient Reported Symptom Burden for NTS-WBRT (normal tissue sparing whole brain radiation therapy)
timeFrame: 4 Months
Secondary outcomes:
measure: Tumor local control Rates between NTS-WBRT+SIB and NTS-WBRT
timeFrame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
measure: Intracranial- Progression Free Survival (PFS) between NTS-WBRT+SIB and NTS-WBRT
timeFrame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
measure: Overall survival (OS) between NTS-WBRT+SIB and NTS-WBRT
timeFrame: The date of randomization to the date of death, or otherwise censored at the last follow-up date for patients still alive up to 24 months
measure: Change in Neurocognitive function between NTS-WBRT+SIB and NTS-WBRT
timeFrame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
measure: Change in Mood between NTS-WBRT+SIB and NTS-WBRT
timeFrame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
measure: Change in Fatigue between NTS-WBRT+SIB and NTS-WBRT
timeFrame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
measure: Change in Neuroendocrine function between NTS-WBRT+SIB and NTS-WBRT
timeFrame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
measure: Change in Hearing between NTS-WBRT+SIB and NTS-WBRT Assessed by Pure Tone Average
timeFrame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
measure: Change in Hearing between NTS-WBRT+SIB and NTS-WBRT Assessed by Word Recognition Score
timeFrame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
measure: Change in Hearing between NTS-WBRT+SIB and NTS-WBRT Assessed by Otoacoustic Emissions
timeFrame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
measure: Alopecia Rates between NTS-WBRT+SIB and NTS-WBRT
timeFrame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Helen A Shih, MD, MS, MPH
role: PRINCIPAL_INVESTIGATOR
References: