NCT06778408

Hybrid Arc Palliative Radiation Therapy (HART): A Single Arm Phase II Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (estimated)
• Sponsor: University of Vermont Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 addressing the lack of clinical data on HART's safety and effectiveness in palliative care.

Conditions

• Palliative Radiotherapy
• Metastatic Cancer (Different Solid Tumour Types)

Interventions

Type	Name	Description
RADIATION	Hybrid Palliative Radiation Therapy	Hybrid Palliative Radiation Therapy will be administered to all patients.

Timeline

• Start date: 2025-04-28
• Primary completion: 2028-02-01
• Completion: 2028-03-01
• First posted: 2025-01-16
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States