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

103 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Hybrid Palliative Radiation Therapy for cancer?

Research shows that palliative radiotherapy is effective in reducing symptoms and improving quality of life for patients with advanced cancer. It provides rapid symptom relief and can decrease hospital stays, highlighting its value in managing advanced malignancies. ^{1 2 3 4 5}

Is Hybrid Arc Palliative Radiation Therapy safe for humans?

Research on palliative radiation therapy, which includes various techniques, suggests that treatment-related toxicities can lead to unplanned hospital admissions, especially when using nonconformal techniques. However, the safety of specific techniques like Hybrid Arc Palliative Radiation Therapy is not directly addressed in the available studies. ^{4 6 7 8 9}

How is Hybrid Arc Palliative Radiation Therapy different from other treatments for cancer?

Hybrid Arc Palliative Radiation Therapy is unique because it combines different radiation techniques to target cancer more precisely, potentially reducing side effects and improving symptom relief compared to traditional palliative radiation methods. ^{10 11 12 13 14}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

Longitudinal symptoms and temporal trends in palliative care, palliative radiotherapy, and anti-cancer treatment near end of life among patients with metastatic cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Novel Inpatient Radiation Oncology Consult Service Model Reduces Hospital Length of Stay. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Palliative Radiotherapy: Inpatients, Outpatients, and the Changing Role of Supportive Care in Radiation Oncology. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Reducing radiotherapy waiting times for palliative patients: The role of the Advanced Practice Radiation Therapist. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

[Pain and quality of life following palliative radiotherapy of bone metastases]. [2018]

6. Ireland pubmed.ncbi.nlm.nih.gov

Diabetes increases the risk of serious adverse events after re-irradiation of the spine. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

The impact of radiation treatment planning technique on unplanned hospital admissions. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Introducing Computed Tomography Simulation-Free and Electronic Patient-Reported Outcomes-Monitored Palliative Radiation Therapy into Routine Care: Clinical Outcomes and Implementation Experience. [2022]

9. Germany 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. [2023]

10. Ireland pubmed.ncbi.nlm.nih.gov

Patterns of practice in palliative radiotherapy for bleeding tumours in the Netherlands; a survey study among radiation oncologists. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Palliative radiotherapy for children: Symptom response and treatment-associated toxicity according to radiation therapy dose and fractionation. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Palliative radiation therapy in oncology. [2006]

13. United States pubmed.ncbi.nlm.nih.gov

Palliative radiation and fractionation in medicare patients with incurable non-small cell lung cancer. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Split-course palliative radiotherapy for advanced non-small cell lung cancer. [2018]