Hybrid Arc (HART) palliative radiation for metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, single-arm Phase II trial testing HART for patients with metastatic solid tumors receiving palliative radiation to thorax, abdomen, or pelvis targets. HART combines dynamic conformal arcs with conventional beams to create more precise dose distributions and spare healthy organs. The primary outcome is the incidence of acute GI toxicity measured by PRO-CTCAE scores compared against historical rates. Secondary outcomes include changes in general and esophageal quality of life, clinician-reported toxicity, dosimetric measures, and pain.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

Exclusion Criteria:

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

Where it's running

• University of Vermont Medical Center
  Burlington, Vermont, United States Recruiting

Study contacts

• Study coordinator: Nataniel H Lester-Coll, MD
• Email: nlesterc@med.uvm.edu
• Phone: (802) 656-2021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.