NTS-WBRT (normal tissue sparing whole brain radiation therapy) for Neoplasm Metastasis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital Cancer Center, Boston, MA
Neoplasm Metastasis+3 More
NTS-WBRT (normal tissue sparing whole brain radiation therapy) - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether there are differences in quality of life and symptom burden between participants who receive two different types of radiation therapy.

See full description

Eligible Conditions

  • Neoplasm Metastasis
  • Tumors Metastatic to Brain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether NTS-WBRT (normal tissue sparing whole brain radiation therapy) will improve 2 primary outcomes and 12 secondary outcomes in patients with Neoplasm Metastasis. Measurement will happen over the course of 4 Months.

4 Months
Change in Patient Reported Quality of Life between NTS-WBRT (normal tissue sparing whole brain radiation therapy) and HA-WBRT (hippocampal avoidance whole brain radiation Therapy)
Change in Patient Reported Symptom Burden between NTS-WBRT (normal tissue sparing whole brain radiation therapy) and HA-WBRT (hippocampal avoidance whole brain radiation Therapy)
Month 24
Overall survival (OS) between NTS-WBRT+SIB and HA-WBRT
Up to 24 months
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Month 24
Alopecia Rates between NTS-WBRT+SIB and HA-WBRT
Change in Fatigue between NTS-WBRT+SIB and HA-WBRT
Change in Hearing between NTS-WBRT+SIB and HA-WBRT Assessed by Otoacoustic Emissions
Change in Hearing between NTS-WBRT+SIB and HA-WBRT Assessed by Pure Tone Average
Change in Hearing between NTS-WBRT+SIB and HA-WBRT Assessed by Word Recognition Score
Change in Mood between NTS-WBRT+SIB and HA-WBRT
Change in Neurocognitive function between NTS-WBRT+SIB and HA-WBRT
Change in Neuroendocrine function between NTS-WBRT+SIB and HA-WBRT
Intracranial- Progression Free Survival (PFS) between NTS-WBRT+SIB and HA-WBRT
Tumor local control Rates between NTS-WBRT+SIB and HA-WBRT

Trial Safety

Trial Design

2 Treatment Groups

NTS-WBRT (normal tissue sparing whole brain radiation therapy) + Memantine
1 of 2
HA-WBRT (hippocampal avoidance whole brain radiation Therapy) + Memantine
1 of 2
Experimental Treatment

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. NTS-WBRT (normal Tissue Sparing Whole Brain Radiation Therapy) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

NTS-WBRT (normal tissue sparing whole brain radiation therapy) + MemantineParticipants 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 (hippocampal avoidance whole brain radiation Therapy) + MemantineParticipants will be randomly assigned to HA-WBRT (hippocampal avoidance whole brain radiation Therapy) administration group and receive: HA-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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Memantine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 2, 4, 6, 9, 12, 18 and 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 2, 4, 6, 9, 12, 18 and 24 months for reporting.

Who is running the study

Principal Investigator
H. A. S.
Helen A. Shih, MD
Massachusetts General Hospital

Closest Location

Massachusetts General Hospital Cancer Center - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

Have there been any new discoveries for treating brain cancer?

"The mainstay of management of [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) is surgery, radiation therapy, and chemotherapy. There have been many advances in the treatment of brain cancer over the last several years, particularly in neuroimaging techniques such as MRI and PET scan imaging. These studies have led to greater understanding of the nature of brain tumors. Brain cancer treatments are now tailored to each patient individually based on their individual needs, which include factors such as age, risks associated with surgery and radiation therapy as well as particular genetic makeup of the tumor. Overall survival rates remain unchanged. However, outcomes vary greatly among individuals depending upon the type of tumor, its location within the brain and the patient's age." - Anonymous Online Contributor

Unverified Answer

What does nts-wbrt (normal tissue sparing whole brain radiation therapy) usually treat?

"Nts-wbrt was found to be beneficial in patients who had a pre-existing neurological condition and/or a previous history of systemic CNS toxicity, all of which are contraindications for WBRT alone. Despite the fact that it has shown no benefit in patients without these characteristics, further studies are warranted to determine whether Nts-Wbrt is beneficial in patients not fulfilling the above criteria." - Anonymous Online Contributor

Unverified Answer

What is the latest research for brain cancer?

"Brain cancer treatment can be divided into three categories: surgery, radiation therapy, or targeting the tumor cells with drugs. Each method results in different types of side effects, which can cause patient discomfort and limit the use of these therapies. Therefore, there are multiple ways to treat brain cancer, including surgery, radiation therapy, targeted therapy, and chemotherapy using drugs. However, some treatments are still under development. In addition, the challenges in dealing with brain tumors range from diagnosis, to survival, to quality of life issues. Furthermore, a consensus guideline for patients suffering from brain cancer is needed to improve patient care." - Anonymous Online Contributor

Unverified Answer

What are common treatments for brain cancer?

"Many of the treatments used for [brain tumor](https://www.withpower.com/clinical-trials/brain-tumor)s have been studied for other cancers, but there are some unique aspects of brain tumor treatment that should be considered. Systemic chemotherapy has been proven effective in treating brain tumors, especially when combined with radiotherapy. However, adjuvant systemic therapy is not routinely recommended due to the need for further evaluation. Temozolomide, vincristine plus temozolomide, and carboplatin deserve special attention because they may worsen seizure control after surgery. Proton radiation is often used in conjunction with radiosurgery and chemotherapy for brain tumors. Microwave ablation has shown promising results when used alone or in conjunction with stereotactic irradiation." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in nts-wbrt (normal tissue sparing whole brain radiation therapy) for therapeutic use?

"Nts-Wbrt has become a standard procedure in the treatment of pediatric brain tumours. A range of new techniques are being explored to further improve outcomes. Targeting of hypoxic areas after radiation may be accomplished by altering the oxygen delivery/delivery ratios. Advances in radiosurgery and image guided irradiation techniques are increasing the effectiveness of treatment." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing brain cancer?

"Brain cancer is relatively uncommon in the United States. However, the lifetime risk of developing brain cancer in a Caucasian man is 1 in 13. This calculation assumes no prior exposure to ionizing radiation, which is known to increase the risk of developing brain cancer by about 15 times. Most health care facilities do not routinely use ionizing radiation, so this is unlikely to overestimate the true overall risk." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving nts-wbrt (normal tissue sparing whole brain radiation therapy)?

"This trial is the first to study the effects of normal tissue sparing on the risk of developing CNS malignancy after whole brain radiation therapy. Data from a recent study indicate that a strategy of reduced dose to critical structures prior to whole brain irradiation does not result in compromise in neurological outcome or improved quality of life." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for brain cancer?

"The current study demonstrates that this is a challenging question to answer as many patients with brain tumors present with multiple metastatic lesions at diagnosis thereby rendering the previous assumption that the brain is a'safe' organ rather than a 'hazard'. The authors hope that the comparison of these findings with those obtained in other studies will allow us to better understand the overall prognosis for patients with brain cancer." - Anonymous Online Contributor

Unverified Answer

Can brain cancer be cured?

"Many people who go by'standard' therapy end up dead from their disease. But, fortunately, treatments are now available for a large number of brain tumors. Newer drugs targeted against some of these tumors show promise in animal models, and work continues to refine their use in humans. Results from a recent clinical trial of clinical trials with these new agents can not yet be expected. However, we anticipate that even if they work, they may take many years before being widely used. Only two therapeutic approaches are currently approved in the United States for the treatment of human brain tumors: surgery and radiation therapy. Other therapies such as immunotherapy are undergoing clinical investigation." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of nts-wbrt (normal tissue sparing whole brain radiation therapy)?

"There were no significant differences between the two groups regarding the most common systemic side effects. However, there was a statistically significant difference regarding the neurological side effects between the two groups. The incidence of neuropathy was significantly greater in the WBRT group than in the NT group (p = 0.0357). Neurological deterioration was more common in WBRT when compared to NT (p = 0.0357). Neurological deterioration did not affect functional outcomes after 6 months." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets brain cancer?

"It is easier for younger people to get brain cancer than older ones. The average age at diagnosis for male patients is 53.7 years and 47.4 years for female patients. The average age of death for male patients is 62.9 years and 59.2 years for female patients. The average age of death for those over 80 years old is 69.6 years and 74.3 years respectively." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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