Hybrid Arc (HART) palliative radiation for metastatic solid tumors
Hybrid Arc Palliative Radiation Therapy (HART): A Single Arm Phase II Trial
This trial tests whether Hybrid Arc Radiation Therapy (HART) lowers acute gastrointestinal side effects in adults with metastatic solid tumors who need palliative radiotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 103 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Vermont Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Burlington, Vermont) |
| Trial ID | NCT06778408 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed metastatic solid tumors who are prescribed palliative radiotherapy to bone, soft tissue, or primary targets in the thorax, abdomen, or pelvis and who agree to required contraception are the intended candidates.
Not a fit: Patients who need palliative radiation only to sites outside the thorax/abdomen/pelvis, those with non-solid (hematologic) malignancies, or those with contraindications to radiation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, HART could reduce acute GI side effects and improve quality of life and treatment tolerance for patients receiving palliative radiation.
How similar studies have performed: Dosimetric and planning studies of hybrid arc techniques have shown improved organ sparing, but clinical evidence for reduced GI toxicity in the palliative setting is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Burlington, Vermont
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.