Personalized radiation therapy for palliative treatment of head and neck cancer
Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy for Palliative Head and Neck Cancer Treatment (PULS-Pal)
This study is testing a new way to give radiation therapy for people with head and neck cancer who can't have regular treatments, to see if it helps control tumors better and reduce side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06572423 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of personalized ultrafractionated stereotactic adaptive radiotherapy (PULSAR) combined with HyperArc radiation treatment planning technology for patients with localized or metastatic head and neck cancer who cannot undergo standard treatments. The approach aims to deliver higher doses of radiation to tumors while minimizing side effects to surrounding healthy tissues. Patients will receive radiation every 14 days, with adjustments made based on any anatomical or tumor changes during treatment. The goal is to improve tumor control and symptom relief in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with primary or recurrent localized or metastatic head and neck cancer who have declined or are ineligible for standard treatment.
Not a fit: Patients with head and neck cancer who are eligible for standard definitive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide better tumor control and symptom management for patients with head and neck cancer who are ineligible for standard therapies.
How similar studies have performed: While there is ongoing research in adaptive radiotherapy, this specific combination of PULSAR and HyperArc is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>= 18 years old * Diagnosis of primary or recurrent, localized or metastatic (American Joint Committee on Cancer (AJCC) 8th Edition stages I-IV) head and neck cancer. In primary diagnosis cases, pathologic confirmation is required. In recurrent and/or metastatic diagnosis cases, pathologic confirmation is not required if not beneficial to the patient as standard of care, and diagnosis can be assumed based on clinical and/or radiographic evidence * Ineligible for or declines standard of care definitive treatment(s), which will be documented in the patient's trial screening progress note in their electronic medical record by the treating physician * Measurable disease within the head and/or neck clinically and/or on imaging studies (CT, PET, MRI) within 30 days from date of enrollment * Patient maximum tumor(s) or tumor bed diameter must be less than 10cm * In a woman of childbearing potential, a negative serum or urine pregnancy test within 1 week of treatment start must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study treatment * Patients with a tracheostomy and/or a percutaneous endoscopic gastrostomy tube are eligible for inclusion Exclusion Criteria: * Pregnant or breast-feeding * More than 1 prior radiation treatment course directed to the treatment area over the patient's lifetime. In patients who have received 1 prior radiation treatment course directed to the treatment area, that prior radiation treatment course must have concluded at least 6 months prior to trial enrollment * Any comorbidity or condition which would limit full compliance with the protocol
Where this trial is running
Los Angeles, California
- University of California at Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Travis Courtney, MD — University of California at Los Angeles
- Study coordinator: Mili Santoso
- Email: msantoso@mednet.ucla.edu
- Phone: 310 267-2153
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.