Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT03892720
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2019-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stereotactic Body Radiation Therapy Using HyperArc in Treating Patients With Recurrent Head and Neck Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Study of Non-Coplanar SBRT Re-Irradiation Using HyperArc in Patients With Recurrent Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well stereotactic body radiation therapy with HyperArc software technology works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate local control and toxicity of patients who receive escalated dose stereotactic body radiation therapy (SBRT) reirradiation with HyperArc for recurrent head and neck cancer (rHNC).
SECONDARY OBJECTIVES:
I. To evaluate the clinical benefit of HyperArc through the analysis of overall survival (OS), progression-free survival (PFS) and locoregional progression-free survival (LPFS).
EXPLORATORY OBJECTIVES:
I. To evaluate dosimetric data including dose to target and organs at risk (OAR).
OUTLINE:
Patients undergo treatment planning with both standard radiation treatment software and HyperArc software technology. The most optimal plan will be delivered to a total dose of 55 Gy in 5 fractions, given 2-3 times weekly.
After completion of study treatment, patients are followed up periodically for 1 year.
I. To evaluate local control and toxicity of patients who receive escalated dose stereotactic body radiation therapy (SBRT) reirradiation with HyperArc for recurrent head and neck cancer (rHNC).
SECONDARY OBJECTIVES:
I. To evaluate the clinical benefit of HyperArc through the analysis of overall survival (OS), progression-free survival (PFS) and locoregional progression-free survival (LPFS).
EXPLORATORY OBJECTIVES:
I. To evaluate dosimetric data including dose to target and organs at risk (OAR).
OUTLINE:
Patients undergo treatment planning with both standard radiation treatment software and HyperArc software technology. The most optimal plan will be delivered to a total dose of 55 Gy in 5 fractions, given 2-3 times weekly.
After completion of study treatment, patients are followed up periodically for 1 year.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-02996 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |