Palliative RadiotherapyPhase 2HARTNCT06778408
Hybrid Arc Palliative Radiation Therapy (HART): A Single Arm Phase II Trial
A Phase 2 study testing Hybrid Palliative Radiation Therapy in people with Palliative Radiotherapy and Metastatic Cancer (Different Solid Tumour Types), run by University of Vermont Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Radiotherapy, Metastatic Cancer (Different Solid Tumour Types)
- What is being tested?
- Hybrid Palliative Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Randall F Holcombe, MD, MBA, 802-656-2021, randall.holcombe@med.uvm.edu
About this study
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.
Read the 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.
- Being tested
- Hybrid Palliative Radiation Therapy
- Keywords
- palliative, radiotherapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Palliative Radiation TherapyRadiation
Hybrid Palliative Radiation Therapy will be administered to all patients.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Arc Palliative Radiation Therapy | Experimental | All patients will receive Hybrid Palliative Radiation Therapy. Receives: Radiation: Hybrid Palliative Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 4 weeks
physician graded toxicity
Assess physician graded toxicity using NCI-CTCAE v5.
Measured: 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.
Measured: 4 weeks
pain scale
To evaluate pain scale changes as a surrogate marker for tumor response from baseline to post-HART.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start28 Apr 2025
- Primary completionFeb 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nataniel Lester-Coll, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778408
- Sponsor's protocol ID
- UVMC2407/STUDY00003447
- Acronym
- HART
- Status last verified
- Feb 2026
- First submitted
- 10 Jan 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Arc Palliative Radiation Therapy (HART): A Single Arm Phase II Trial
- ClinicalTrials.gov ID
- NCT06778408
- Acronym / sponsor ID
- HART / UVMC2407/STUDY00003447
- Keywords
- palliative, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid Arc Palliative Radiation Therapy | Experimental | Radiation: Hybrid Palliative Radiation TherapyAll patients will receive Hybrid Palliative Radiation Therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Palliative Radiation TherapyHybrid Palliative Radiation Therapy will be administered to all patients. | Radiation | Hybrid Arc Palliative Radiation Therapy |
Primary outcome
Incidence of acute gastrointestinal (GI) toxicity
Time frame: 4 weeks
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.
5 secondary outcomes
patient-reported health-related quality of life
Time frame: 4 weeks
patient-reported esophageal quality of life
Time frame: 4 weeks
physician graded toxicity
Time frame: 4 weeks
dosimetric outcomes of HART
Time frame: 4 weeks
pain scale
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No. Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hybrid Palliative Radiation Therapy in people with Palliative Radiotherapy and Metastatic Cancer (Different Solid Tumour Types), run by University of Vermont Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nataniel H Lester-Coll, MD ((802) 656-2021, nlesterc@med.uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute gastrointestinal (GI) toxicity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.