Phase II Trial of Normal Tissue Sparing Whole Brain Radiation Therapy (NTS-WBRT) in Patients With Brain Metastases
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.
Arms & interventions
- RadiationNTS-WBRT (normal tissue sparing whole brain radiation therapy)
Radiation
- DrugMemantine
Capsule, taken orally
Outcome measures
Primary
Change in Patient Reported Quality of Life for NTS-WBRT (normal tissue sparing whole brain radiation therapy)
Assessed by Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire. Score range is 0-200 and the higher the score, the better the outcome.
Time frame: 4 Months
Change in Patient Reported Symptom Burden for NTS-WBRT (normal tissue sparing whole brain radiation therapy)
Assessed by Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire. Score range is 0-200 and the higher the score, the better the outcome.
Time frame: 4 Months
Secondary
Tumor local control Rates between NTS-WBRT+SIB and NTS-WBRT
Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
Intracranial- Progression Free Survival (PFS) between NTS-WBRT+SIB and NTS-WBRT
Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
Overall survival (OS) between NTS-WBRT+SIB and NTS-WBRT
Time frame: 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
Change in Neurocognitive function between NTS-WBRT+SIB and NTS-WBRT
Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
Change in Mood between NTS-WBRT+SIB and NTS-WBRT
Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
Change in Fatigue between NTS-WBRT+SIB and NTS-WBRT
Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
Change in Neuroendocrine function between NTS-WBRT+SIB and NTS-WBRT
Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
Change in Hearing between NTS-WBRT+SIB and NTS-WBRT Assessed by Pure Tone Average
Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
Change in Hearing between NTS-WBRT+SIB and NTS-WBRT Assessed by Word Recognition Score
Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
Change in Hearing between NTS-WBRT+SIB and NTS-WBRT Assessed by Otoacoustic Emissions
Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
Alopecia Rates between NTS-WBRT+SIB and NTS-WBRT
Time frame: baseline, 2, 4, 6, 9, 12, 18 and 24 months
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Time frame: Up to 24 months
Eligibility criteria
Study locations (1)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114