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

NCT06778408 | Recruiting Phase 2 DMC

• 1 other identifier: UVMC2407/STUDY00003447
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Palliative Radiotherapy; Metastatic Cancer (Different Solid Tumour Types)

Keywords

palliative; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• patient-reported health-related quality of life

  4 weeks

• patient-reported esophageal quality of life

  4 weeks

• physician graded toxicity

  4 weeks

• dosimetric outcomes of HART

  4 weeks

• pain scale

  4 weeks

Study Arms (1)

Hybrid Arc Palliative Radiation Therapy

EXPERIMENTAL

All patients will receive Hybrid Palliative Radiation Therapy.

Radiation: Hybrid Palliative Radiation Therapy

Interventions

Hybrid Palliative Radiation Therapy RADIATION

Hybrid Palliative Radiation Therapy will be administered to all patients.

Hybrid Arc Palliative Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nataniel H Lester-Coll, MD

CONTACT

(802) 656-2021; nlesterc@med.uvm.edu

Christopher Anker, MD

CONTACT

(802) 656-2021; chris.anker@uvmhealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)