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

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Cancer (Different Solid Tumour Types); Palliative Radiotherapy
• Intervention / Treatment: Radiation: Hybrid Palliative Radiation Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 103
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nataniel H Lester-Coll, MD; Phone Number: (802) 656-2021; Email: nlesterc@med.uvm.edu
• Study Contact Backup: Name: Christopher Anker, MD; Phone Number: (802) 656-2021; Email: chris.anker@uvmhealth.org

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Recruiting
      • University of Vermont Medical Center
      • Contact: Randall F Holcombe, MD, MBA; Phone Number: 802-656-2021; Email: randall.holcombe@med.uvm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 this study, she should inform her treating physician immediately.

In lieu of a pregnancy test, participants may sign the Pregnancy Attestation Form, a standard form routinely used in clinical practice at UVMCC.

Recommended methods of birth control are:

The consistent use of an approved hormonal contraception (birth control pill/patches, rings), An intrauterine device (IUD), Contraceptive injection (Depo-Provera), Double barrier methods (Diaphragm with spermicidal gel or condoms with contraceptive foam), Sexual abstinence (no sexual intercourse) or Sterilization.

Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after completion of therapy.

A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

Patients receiving any other investigational agents or concurrent cytotoxic chemotherapy

Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Serious medical comorbidities, which in the opinion of the radiation oncologist preclude the delivery of RT

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hybrid Arc Palliative Radiation Therapy; All patients will receive Hybrid Palliative Radiation Therapy.	Radiation: Hybrid Palliative Radiation Therapy; Hybrid Palliative Radiation Therapy will be administered to all patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence 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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	4 weeks
physician graded toxicity	Assess physician graded toxicity using NCI-CTCAE v5.	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.	4 weeks
pain scale	To evaluate pain scale changes as a surrogate marker for tumor response from baseline to post-HART.	4 weeks

Collaborators and Investigators

• Sponsor: University of Vermont Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): January 16, 2025

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: radiotherapy; palliative
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis
• Other Study ID Numbers: UVMC2407/STUDY00003447

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No