Clinical trial · Interventional
Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy for Palliative Head and Neck Cancer Treatment (PULS-Pal)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial tests how well personalized ultra fractionated stereotactic adaptive radiotherapy (PULSAR) works together with HyperArc© radiation treatment planning technology for palliative (holistic pain and symptom control) tumor control in patients with primary or recurrent, localized or metastatic head and neck cancer (HNC) who are ineligible for or decline standard of care treatment. Researchers want to evaluate if using HyperArc and PULSAR together will deliver higher, possibly more effective doses, resulting in better tumor control with the same or fewer side effects than smaller routine doses. PULSAR is a radiation therapy regimen that uses a limited number of fairly large dose pulses while adjusting to specific anatomic and/or biological changes which may occur during the course of the treatment. HyperArc radiation treatment planning technology is a tool that allows for target dose escalation to tumor tissue while maintaining minimal head and neck organs-at-risk doses compared to other radiation treatment planning software. Undergoing PULSAR and HyperArc technology together may be a safe and effective palliative treatment option for patients with HNC.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Localized Head and Neck Carcinoma | Head and Neck Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Head and Neck Carcinoma | Head and Neck Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Head and Neck Carcinoma | Head and Neck Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Functional Assessment of Cancer Therapy-Head & Neck | Behavioral | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Personalized ultrafractionated stereotactic adaptive radiotherapy | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| University of Washington Quality of Life Scale, Version 4 | Behavioral | — | UNRESOLVED |
| Volume Modulated Arc Therapy | Radiation |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (PULSAR and HyperArc)
- description
- Patients undergo standard of care CT simulation for radiation treatment planning using HyperArc software. 1 week later, patients undergo PULSAR fraction therapy once daily on days 0, 14, 28, 42, and 56. Patients may also undergo Positron Emission Tomography (PET) scan and MRI during follow-up.
- interventionNames
- Procedure: Personalized ultrafractionated stereotactic adaptive radiotherapy
- Radiation: Volume Modulated Arc Therapy
- Procedure: Computed Tomography
- Procedure: Positron Emission Tomography
- Procedure: Magnetic Resonance Imaging
- Other: Best Practice
- Behavioral: University of Washington Quality of Life Scale, Version 4
- Behavioral: Functional Assessment of Cancer Therapy-Head & Neck
Primary outcomes (1)
- measure
- Time to progression of the treated tumor target
- timeFrame
- From baseline up to 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCourtney PT, L Santoso M, Savjani RR, K Reddy V, Chai-Ho W, Velez Velez MA, J Wong D, Palodichuk C, Basehart TV, P O'Connell D, Cao M, Telesca D, Chin RK. A phase II study of personalized ultrafractionated stereotactic adaptive radiotherapy for palliative head and neck cancer treatment (PULS-Pal): a single-arm clinical trial protocol. BMC Cancer. 2024 Dec 21;24(1):1564. doi: 10.1186/s12885-024-13303-5. PMID 39709372