Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy for the Treatment of Cancer, SMART Study

PRIMARY OBJECTIVES:

I. To determine feasibility and safety of utilizing SMART in patients with cancer. (Phase I)

II. To evaluate if SMART improves patient reported outcomes (PROM’s) and 1-year tumor control of patients over historical cohorts. (Phase II)

SECONDARY OBJECTIVES:

I. Assessing acute (90 days) toxicity in patients receiving SMART, evaluating patient-reported outcomes (PROM’s) of patients undergoing SMART and evaluating local control (LC) of patients undergoing SMART. (Phase I)

II. Assessing long-term (12 month) toxicity in patients receiving SMART, characterizing MRI-based tumor alterations/changes following SMART, assess disease-specific survival, and overall survival in patients receiving SMART. (Phase II)

EXPLORATORY OBJECTIVES:

I. To investigate the biologic, molecular, immunogenic and radiographic activity of patients receiving SMART and potentially identify clinical or imaging biomarkers predictive of radiation response.

II. To evaluate cost-effectiveness, operational efficiency, and patient satisfaction, including patient-reported tolerability of SMART.

III. To explore patient communication around advanced technologies by describing pre-treatment sociodemographic and clinical characteristics, knowledge about MR Linac, attitudes towards technology, therapeutic misconception, and patient self-perceptions of hope, risk, and prognosis.

IV. To explore associations between sociodemographic and clinical characteristics and pre-treatment patient self-perceptions, therapeutic misconception, and knowledge/attitudes.

V. To explore associations between sociodemographic and clinical characteristics, pre-treatment patient self-perceptions, therapeutic misconception, and knowledge/attitudes, and post-treatment decision regret and perception of informed consent quality.

OUTLINE:

Patients undergo SMART in 5 fractions every other day over 1-2.5 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4-8 weeks, then every 3-6 months for 1 year, and periodically thereafter.