This is a prospective single-center single-arm Phase II trial of HART for patients with metastatic cancer. The primary objective is to assess the incidence of acute GI toxicity following HART. PRO-CTCAE GI scores observed in the study patients will be compared to historical rates. Secondary outcomes include measuring changes in health-related quality of life, esophageal quality of life, toxicity, dosimetric outcomes, and pain.
Palliative radiation therapy is often used to improve quality of life for patients with metastatic cancer, but severe gastrointestinal (GI) toxicities can limit its effectiveness. HART (Hybrid Arc Radiation Therapy) combines dynamic conformal arcs with conventional radiation beams to deliver more precise dose distributions while sparing healthy organs. This study explores whether HART can reduce acute GI toxicities compared to traditional methods, using validated measures like PRO-CTCAE scores. The goal is to improve patient adherence, reduce side effects, and enhance quality of life, while addressing the lack of clinical data on HART's safety and effectiveness in palliative care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Hybrid Palliative Radiation Therapy will be administered to all patients.
University of Vermont Medical Center
Burlington, Vermont, United States
RECRUITINGIncidence of acute gastrointestinal (GI) toxicity
Th incidence of acute gastrointestinal (GI) toxicity (defined as a score of ≥2) at 4 weeks post-treatment initiation will be measured and compared to historical data, using PRO-CTCAE GI scores to determine if HART reduces GI toxicity.
Time frame: 4 weeks
patient-reported health-related quality of life
Changes in patient-reported health-related quality of life (HRQOL) following HART treatment will be measured, as assessed by the EORTC QLQ-C15-PAL questionnaire from baseline measurements.
Time frame: 4 weeks
patient-reported esophageal quality of life
To assess changes in patient-reported esophageal quality of life (QOL) following HART, as measured by the Esophageal Cancer Subscale (ECS) of the FACT-E for thoracic disease, from baseline measurements.
Time frame: 4 weeks
physician graded toxicity
Assess physician graded toxicity using NCI-CTCAE v5.
Time frame: 4 weeks
dosimetric outcomes of HART
To compare the dosimetric outcomes of HART and conventional AP/PA plans by analyzing dose-volume histograms, with a specific focus on the gastrointestinal organs at risk.
Time frame: 4 weeks
pain scale
To evaluate pain scale changes as a surrogate marker for tumor response from baseline to post-HART.
Time frame: 4 weeks
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