Hybrid Arc Palliative Radiation Therapy for Cancer
(HART Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Vermont Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

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 am 18 years old or older.

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.

+1 more

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.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Hybrid Arc Palliative Radiation TherapyExperimental Treatment1 Intervention

All patients will receive Hybrid Palliative Radiation Therapy.