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

Part of paid clinical trials in Burlington, Vermont.

Sponsor
University of Vermont Medical Center
Study ID
NCT06778408
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hybrid Palliative Radiation Therapy — RADIATION
    Hybrid Palliative Radiation Therapy will be administered to all patients.

Study Details

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.

Key Dates

Start date
Apr 28, 2025
Status verified
Feb 2026
Primary completion
Feb 29, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
103 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Hybrid Arc Palliative Radiation Therapy
    All patients will receive Hybrid Palliative Radiation Therapy.

Primary Outcome Measure

Incidence of acute gastrointestinal (GI) toxicity [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Vermont Medical CenterBurlingtonVermont05401
Randall F Holcombe, MD, MBA
[email protected]
802-656-2021

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University of Vermont Medical Center· Burlington, VT

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