Status:
RECRUITING
Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy for Palliative Head and Neck Cancer Treatment (PULS-Pal)
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Varian Medical Systems
Conditions:
Head and Neck Carcinoma
Localized Head and Neck Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial tests how well personalized ultra fractionated stereotactic adaptive radiotherapy (PULSAR) works together with HyperArc© radiation treatment planning technology for palliative (holistic pai...
Detailed Description
A significant proportion of patients with de novo or recurrent head and neck cancer are not candidates for standard-of-care definitive treatment(s), including standard-of-care stereotactic body radiat...
Eligibility Criteria
Inclusion
- \>= 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
- 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
Key Trial Info
Start Date :
October 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 16 2029
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06572423
Start Date
October 25 2024
End Date
December 16 2029
Last Update
January 9 2025
Active Locations (1)
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1
University of California at Los Angeles
Los Angeles, California, United States, 90095