This phase II trial studies the effect of normal tissue sparing whole brain radiation therapy (NTS-WBRT) in treating patients with cancer that has spread to the brain (brain metastases). NTS-WBRT is a targeted radiation therapy that further reduces radiation dose to tissue that does not need radiation therapy treatment. This trial may help doctors assess quality of life and symptom burden in participants who receive NTS-WBRT. An additional goal of this study is to further reduce damage to cognitive function of the brain, and to reduce hair loss and hearing loss through decreased radiation via NTS-WBRT.
Additional locations may be listed on ClinicalTrials.gov for NCT05013892.
Locations matching your search criteria
United States
Massachusetts
Boston
Massachusetts General Hospital Cancer CenterStatus: Active
Contact: Helen A Shih
Phone: 617-724-9627
Danvers
Mass General/North Shore Cancer CenterStatus: Active
Contact: Daniel Enrique Soto
PRIMARY OBJECTIVE:
I. To assess the quality of life (QOL) and symptom burden in patients at 4 months after receiving normal tissue sparing whole brain radiation therapy with simultaneous integrated boost (NTS-WBRT+SIB) using the Functional Assessment of Cancer Therapy (FACT)-Brain questionnaire.
SECONDARY OBJECTIVES:
I. To assess the QOL and symptom trajectory longitudinally (baseline, 2, 4, 6, 9, 12, 18 and 24 months) in adult patients with brain metastases following NTS-WBRT + SIB.
II. To assess brain metastases local control (LC) following NTS-WBRT+SIB.
III. To assess intracranial progression-free survival (I-PFS) following NTS-WBRT+SIB.
IV. To determine the overall survival (OS) following NTS-WBRT+SIB.
V. To assess psychological distress.
VI. To evaluate the fatigue level in adults following NTS-WBRT+SIB.
VII. To evaluate the neurocognitive function in adult patients with brain metastases following NTS-WBRT+SIB.
VIII. To evaluate neuroendocrine function in adult patients with brain metastases following NTS-WBRT+SIB.
IX. To determine changes in hearing following NTS-WBRT+SIB.
X. To assess alopecia following NTS-WBRT+SIB.
XI. To identify toxicity using Common Terminology Criteria for Adverse Events version 5 (CTCAEv5) in adult patients with brain metastases following NTS-WBRT+SIB.
XII. To identify the toxicity between frail and non-frail patients using Vulnerable Elders Survey (VES)-13 questionnaire.
OUTLINE:
Patients receive NTS-WBRT+SIB daily, 5 days per week (typically Monday-Friday) over 10 or 15 treatment fractions (2-3 weeks). Patients also receive memantine orally (PO) once or twice daily (QD or BID) for up to 28 weeks. Patients undergo magnetic resonance imaging (MRI) throughout the study. Patients also undergo blood sample collection at baseline.
After completion of study treatment, patients are followed up at 2, 4, 6, 9, 12, 18, and 24 months or until death, whichever occurs first.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorHelen A Shih