Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572423
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy for Palliative Head and Neck Cancer Treatment PULS-Pal
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy for Palliative Head and Neck Cancer Treatment PULS-Pal
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PULS-Pal
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 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 andor 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
Detailed Description:
A significant proportion of patients with de novo or recurrent head and neck cancer are not candidates for standard-of-care definitive treatments including standard-of-care stereotactic body radiation therapy SBRT Current palliative radiation therapy regimens result in adequate symptom improvement though with suboptimal local control andor toxicity The durability of symptom and local control in these patients is becoming more important as advances in systemic therapy are improving these patients survival
After confirmation of eligibility enrolled patients will undergo radiation simulation and planning per standard of care HyperArc technology will be used for treatment planning given prior internal validation of its superiority Dosimetric constraints will be adapted from the available literature as appropriate Patients will receive an 11 Gray fraction of radiation to the head and neck tumor site every 14 -10 days
It is possible that patients will experience anatomical andor tumor changes during the radiation therapy course such that patient alignment for radiation therapy is no longer optimized to the original CT simulation and radiation plan In such cases where it is determined that adaptive planning is needed the Investigators will abort planned radiation therapy and immediately perform re-simulation and re-planning if the anatomic change is significant enough to put adjacent normal tissue at significant risk otherwise the Investigators will re-plan with the next fraction of radiation to minimize treatment delays This will be determined by the treating physician through standard of care clinical criteria and procedures
The frequency of re-simulation and adaptive planning as well as associated changes in dosimetry will be measured Patients will receive 5 PULSAR fractions for a total radiation dose of 55 Gray Treatment will be terminated early in cases of intolerable treatment-related toxicity altered clinical context or the patient declines further treatment
Enrolled patients are permitted to receive systemic therapy at the discretion of their medical oncologist
Patient follow-up will be measured from the time of receipt of first PULSAR fraction to 12 months after receipt of the last PULSAR fraction
After confirmation of eligibility enrolled patients will undergo radiation simulation and planning per standard of care HyperArc technology will be used for treatment planning given prior internal validation of its superiority Dosimetric constraints will be adapted from the available literature as appropriate Patients will receive an 11 Gray fraction of radiation to the head and neck tumor site every 14 -10 days
It is possible that patients will experience anatomical andor tumor changes during the radiation therapy course such that patient alignment for radiation therapy is no longer optimized to the original CT simulation and radiation plan In such cases where it is determined that adaptive planning is needed the Investigators will abort planned radiation therapy and immediately perform re-simulation and re-planning if the anatomic change is significant enough to put adjacent normal tissue at significant risk otherwise the Investigators will re-plan with the next fraction of radiation to minimize treatment delays This will be determined by the treating physician through standard of care clinical criteria and procedures
The frequency of re-simulation and adaptive planning as well as associated changes in dosimetry will be measured Patients will receive 5 PULSAR fractions for a total radiation dose of 55 Gray Treatment will be terminated early in cases of intolerable treatment-related toxicity altered clinical context or the patient declines further treatment
Enrolled patients are permitted to receive systemic therapy at the discretion of their medical oncologist
Patient follow-up will be measured from the time of receipt of first PULSAR fraction to 12 months after receipt of the last PULSAR fraction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None