Hybrid Arc Palliative Radiation Therapy for Cancer

(HART Trial)

Overseen By Christopher Anker, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Vermont Medical Center

Must not be taking: Investigational agents, Cytotoxic chemotherapy

Disqualifiers: Pregnancy, Nursing, Serious medical comorbidities

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to radiation therapy designed to ease symptoms for individuals with metastatic cancer, where the cancer has spread to other parts of the body. The main goal is to determine if this treatment causes any immediate stomach or digestive issues and how these compare to typical rates. Researchers are also examining the treatment's impact on overall well-being, pain, and specific areas like the esophagus. This trial may suit individuals with confirmed metastatic cancer who require radiation therapy for tumors in areas such as the chest or stomach. Participants must also be able to prevent pregnancy during the study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are receiving other investigational agents or concurrent cytotoxic chemotherapy (a type of cancer treatment).

What prior data suggests that Hybrid Arc Palliative Radiation Therapy is safe for patients with metastatic cancer?

Research is investigating whether Hybrid Arc Palliative Radiation Therapy (HART) causes fewer stomach-related side effects than traditional radiation methods. Current studies lack direct safety data on HART, but they aim to determine if it results in fewer gut issues.

The trial is in Phase 2, indicating that HART has passed initial safety tests. This suggests it is likely safe enough for further testing, though more information is needed to fully understand its safety. Participants will help researchers learn more about any side effects and how well people tolerate the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Hybrid Palliative Radiation Therapy is unique because it combines traditional radiation therapy techniques into a single, more efficient treatment approach. Unlike standard radiation therapy, which often involves multiple sessions and targeting methods, Hybrid Arc streamlines the process to potentially reduce treatment time and improve patient comfort. Researchers are excited about this therapy because it aims to deliver effective palliation with fewer side effects, enhancing the quality of life for patients with advanced cancer.

What evidence suggests that Hybrid Arc Palliative Radiation Therapy could be effective for metastatic cancer?

Research has shown that Hybrid Arc Palliative Radiation Therapy (HART), which all participants in this trial will receive, can help reduce symptoms in people with advanced cancer. Studies have found that HART quickly eases cancer symptoms while having less impact on patients' quality of life compared to traditional treatments. Evidence also suggests that HART might lower the risk of sudden stomach and intestinal problems, common side effects of radiation. The therapy aims to improve overall health and ease swallowing difficulties for patients. Overall, HART could be a promising option for managing symptoms in advanced cancer. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with metastatic cancer needing palliative radiotherapy for areas like the thorax, abdomen, or pelvis. They must have confirmed cancer and agree to use contraception. It's not open to those on other investigational drugs, pregnant or nursing women, or individuals with serious medical issues that radiation therapy would worsen.

Inclusion Criteria

I need radiation for cancer spread to bones or soft tissues in my chest, belly, or pelvis.

My cancer is confirmed and has spread, as shown by scans.

I agree to use effective birth control during and after the study.

Exclusion Criteria

I am not on any experimental drugs or chemotherapy.

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

I have serious health issues that prevent me from receiving radiation therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive Hybrid Arc Palliative Radiation Therapy (HART) to assess its impact on acute GI toxicity and quality of life

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on acute GI toxicity and quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hybrid Palliative Radiation Therapy

Trial Overview The study tests Hybrid Arc Palliative Radiation Therapy (HART) in patients with metastatic cancer. The main goal is to see how this treatment affects acute gastrointestinal toxicity compared to past data. Other focuses include quality of life, esophageal health, additional toxicities, dosimetric outcomes, and pain management.

How Is the Trial Designed?

Group I: Hybrid Arc Palliative Radiation Therapy Experimental Treatment 1 Intervention

All patients will receive Hybrid Palliative Radiation Therapy.

Who Is Running the Clinical Trial?

University of Vermont Medical Center

Lead Sponsor

Trials

46

Recruited

25,900+

Published Research Related to This Trial

Out of 4566 abstracts reviewed from 2003 to 2021, only 7.4% (339 abstracts) were focused on palliative radiotherapy, indicating a growing but still limited emphasis on this important area of cancer care.

The most common focus of palliative research was on lung cancer and bone metastases, with pain being the primary symptom addressed, highlighting the need for more studies aimed at improving quality of life and symptom management in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of palliative radiotherapy abstracts presented at the annual scientific meetings of the Canadian Association of Radiation Oncology: 2003-2021. Sidhoo, S., Ghosh, S., Barnes, EA., et al.[2023]

Palliative radiation therapy is effective in relieving symptoms related to incurable cancer, such as pain, bleeding, and airway obstruction, by targeting either the primary tumor or metastatic lesions.

Various techniques, including external beam radiation and brachytherapy, can be used to deliver palliative radiation, making it a versatile option for managing tumor-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative radiation therapy in oncology. Dolinsky, C., Metz, JM.[2006]

In a study of 220 patients who received re-irradiation for metastatic spinal cord compression, the incidence of serious adverse events like radiation-induced myelopathy (RIM) and radiation-induced vertebral fracture (RIF) was low, with only 6 and 9 cases respectively.

Diabetes was identified as a significant risk factor for increased toxicity from re-irradiation, suggesting that careful consideration of a patient's diabetes status is important before proceeding with spinal re-irradiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes increases the risk of serious adverse events after re-irradiation of the spine. Suppli, MH., Munck Af Rosenschöld, P., Pappot, H., et al.[2020]

Palliative radiotherapy is effective in quickly alleviating symptoms of advanced cancer, allowing for rapid relief with minimal impact on patients' quality of life.

Dedicated palliative radiotherapy programs have emerged over the past 20 years, focusing on holistic care and addressing patients' broader concerns, which has led to improved patient-focused outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Radiotherapy: Inpatients, Outpatients, and the Changing Role of Supportive Care in Radiation Oncology. Arscott, WT., Emmett, J., Ghiam, AF., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06778408

Hybrid Arc Palliative Radiation Therapy (HART): a Single ... 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 ...

2. withpower.com withpower.com/trial/hybrid-arc-palliative-radiation-therapy-for-cancer-cc8cf

Hybrid Arc Palliative Radiation Therapy for Cancer Palliative radiotherapy is effective in quickly alleviating symptoms of advanced cancer, allowing for rapid relief with minimal impact on patients' quality of ...

3. ctv.veeva.com ctv.veeva.com/study/hybrid-arc-palliative-radiation-therapy-hart-a-single-arm-phase-ii-trial

Hybrid Arc Palliative Radiation Therapy (HART): a Single Arm ... Secondary outcomes include measuring changes in health-related quality of life, esophageal quality of life, toxicity, dosimetric outcomes, and ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-2-hybrid-arc-palliative-radiation-therapy-hart-single-arm-ii-trial-nct06778408

Hybrid Arc Palliative Radiation Therapy (HART) This study aims to assess the effectiveness of a new radiation therapy technique called Hybrid Arc Palliative Radiation Therapy (HART) in reducing ...

5. scholarworks.gvsu.edu scholarworks.gvsu.edu/cgi/viewcontent.cgi?article=1663&context=gradprojects

Optimizing Palliative Spine Radiation - ScholarWorks@GVSU The purpose of this study is to compare treatment plans generated using Hybrid Arc. Palliative Radiation Therapy (HART) with those created using ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12512287/

Study protocol: feasibility and safety of conventional ... Discussion. This protocol evaluates a hybrid EBRT approach with a simultaneous integrated boost as a practical strategy to enhance local tumour ...