Hybrid Arc Palliative Radiation Therapy (HART): A Single Arm Phase II Trial
University of Vermont Medical Center
Summary
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.
Description
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 ad…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Histological confirmation of cancer with radiographic (CT, MRI or PET) evidence of metastatic disease Palliative radiotherapy indicated for bone or soft tissue metastases, or primary targets, located in the thorax, abdomen, or pelvis as part of their standard of care treatment plan Age ≥ 18 years. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in th…
Interventions
- RadiationHybrid Palliative Radiation Therapy
Hybrid Palliative Radiation Therapy will be administered to all patients.
Location
- University of Vermont Medical CenterBurlington, Vermont