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Stereotactic Body Radiation Therapy Using HyperArc in Treating Patients With Recurrent Head and Neck Cancer

Primary Purpose

Recurrent Head and Neck Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality-of-Life Assessment
Questionnaire Administration
Stereotactic Body Radiation Therapy
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Head and Neck Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed recurrent head and neck cancer; either unresectable or status post salvage surgery.
  • History of radiation therapy for head and neck cancer with minimum 50% overlap of the 50% isodose line from prior treatment to the proposed treatment volume.
  • Estimated life expectancy > 12 weeks.
  • Karnofsky performance status >= 70 (Eastern Cooperative Oncology Group [ECOG] 0-2).
  • Maximum tumor, or tumor bed, diameter < 5 cm.
  • If a woman is of childbearing potential, a negative serum pregnancy test 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.
  • Ability to understand and willingness to sign a written informed consent.

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (SBRT)

Arm Description

Patients undergo stereotactic body radiation therapy with either standard radiation treatment software or HyperArc software technology for 2-3 fractions per week over a 2-week period for 5 fractions.

Outcomes

Primary Outcome Measures

Local control rate of the treated tumor target per Response Evaluation Criteria in Solid Tumors version 1.1, magnetic resonance imaging (MRI) response or positron emission tomography (PET) response
Will calculate the percentage and construct 95% exact confidence interval for local control rate.
Percent of patients with acute or chronic grade >= 3 treatment-related toxicity per Common Terminology Criteria for Adverse Events version 4.0
Data will be tabulated and summarized. Incidence of adverse events (AEs) will be summarized overall and with separate summaries for serious adverse events (SAEs), AEs leading to discontinuation, AEs leading to death, etc. The overall safety and tolerability will be assessed throughout the study period. All AE data will be listed individually by patient identifier.

Secondary Outcome Measures

Overall survival (OS)
The Kaplan-Meier method will be used to provide an estimate of OS. The corresponding 95% confidence interval will also be presented.
OS
The Kaplan-Meier method will be used to provide an estimate of OS. The corresponding 95% confidence interval will also be presented.
Median OS
The Kaplan-Meier method will be used to provide an estimate of median OS. The corresponding 95% confidence interval will also be presented.
Progression-free survival (PFS)
The Kaplan-Meier method will be used to provide an estimate of PFS. The corresponding 95% confidence interval will also be presented.
PFS
The Kaplan-Meier method will be used to provide an estimate of PFS. The corresponding 95% confidence interval will also be presented.
Median PFS
The Kaplan-Meier method will be used to provide an estimate of median PFS. The corresponding 95% confidence interval will also be presented.
Locoregional progression-free survival (LPFS)
The Kaplan-Meier method will be used to provide an estimate of LPFS. The corresponding 95% confidence interval will also be presented.
LPFS
The Kaplan-Meier method will be used to provide an estimate of LPFS. The corresponding 95% confidence interval will also be presented.
Median LPFS
The Kaplan-Meier method will be used to provide an estimate of median LPFS. The corresponding 95% confidence interval will also be presented.

Full Information

First Posted
March 26, 2019
Last Updated
April 10, 2023
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Varian, a Siemens Healthineers Company
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1. Study Identification

Unique Protocol Identification Number
NCT03892720
Brief Title
Stereotactic Body Radiation Therapy Using HyperArc in Treating Patients With Recurrent Head and Neck Cancer
Official Title
A Phase II Study of Non-Coplanar SBRT Re-Irradiation Using HyperArc in Patients With Recurrent Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Varian, a Siemens Healthineers Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Head and Neck Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (SBRT)
Arm Type
Experimental
Arm Description
Patients undergo stereotactic body radiation therapy with either standard radiation treatment software or HyperArc software technology for 2-3 fractions per week over a 2-week period for 5 fractions.
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Intervention Description
Undergo SBRT
Primary Outcome Measure Information:
Title
Local control rate of the treated tumor target per Response Evaluation Criteria in Solid Tumors version 1.1, magnetic resonance imaging (MRI) response or positron emission tomography (PET) response
Description
Will calculate the percentage and construct 95% exact confidence interval for local control rate.
Time Frame
At 1 year
Title
Percent of patients with acute or chronic grade >= 3 treatment-related toxicity per Common Terminology Criteria for Adverse Events version 4.0
Description
Data will be tabulated and summarized. Incidence of adverse events (AEs) will be summarized overall and with separate summaries for serious adverse events (SAEs), AEs leading to discontinuation, AEs leading to death, etc. The overall safety and tolerability will be assessed throughout the study period. All AE data will be listed individually by patient identifier.
Time Frame
At 1 year
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
The Kaplan-Meier method will be used to provide an estimate of OS. The corresponding 95% confidence interval will also be presented.
Time Frame
The time between the first dose of stereotactic body radiation therapy (SBRT) and death, assessed at 1 year
Title
OS
Description
The Kaplan-Meier method will be used to provide an estimate of OS. The corresponding 95% confidence interval will also be presented.
Time Frame
The time between the first dose of SBRT and death, assessed at 2 years
Title
Median OS
Description
The Kaplan-Meier method will be used to provide an estimate of median OS. The corresponding 95% confidence interval will also be presented.
Time Frame
The time between the first dose of SBRT and death, assessed up to 2 years
Title
Progression-free survival (PFS)
Description
The Kaplan-Meier method will be used to provide an estimate of PFS. The corresponding 95% confidence interval will also be presented.
Time Frame
From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed at 1 year
Title
PFS
Description
The Kaplan-Meier method will be used to provide an estimate of PFS. The corresponding 95% confidence interval will also be presented.
Time Frame
From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed at 2 years
Title
Median PFS
Description
The Kaplan-Meier method will be used to provide an estimate of median PFS. The corresponding 95% confidence interval will also be presented.
Time Frame
From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed up to 2 years
Title
Locoregional progression-free survival (LPFS)
Description
The Kaplan-Meier method will be used to provide an estimate of LPFS. The corresponding 95% confidence interval will also be presented.
Time Frame
From the first dose of SBRT to the first objectively documented disease progression in either the primary tumor, adjacent to the primary tumor, or in the surrounding lymph node areas, assessed at 1 year
Title
LPFS
Description
The Kaplan-Meier method will be used to provide an estimate of LPFS. The corresponding 95% confidence interval will also be presented.
Time Frame
From the first dose of SBRT to the first objectively documented disease progression in either the primary tumor, adjacent to the primary tumor, or in the surrounding lymph node areas, assessed at 2 years
Title
Median LPFS
Description
The Kaplan-Meier method will be used to provide an estimate of median LPFS. The corresponding 95% confidence interval will also be presented.
Time Frame
From the first dose of SBRT to the first objectively documented disease progression in either the primary tumor, adjacent to the primary tumor, or in the surrounding lymph node areas, assessed up to 2 years
Other Pre-specified Outcome Measures:
Title
Dosimetric data including achievable dose to target and organs at risk (OAR)
Description
Data will be collected but not analyzed.
Time Frame
Up to 2 years
Title
Serum markers predictive of response and/or toxicity
Description
Will perform correlation analysis to explore serum markers predictive of efficacy endpoints.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed recurrent head and neck cancer; either unresectable or status post salvage surgery. History of radiation therapy for head and neck cancer with minimum 50% overlap of the 50% isodose line from prior treatment to the proposed treatment volume. Estimated life expectancy > 12 weeks. Karnofsky performance status >= 70 (Eastern Cooperative Oncology Group [ECOG] 0-2). Maximum tumor, or tumor bed, diameter < 5 cm. If a woman is of childbearing potential, a negative serum pregnancy test 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. Ability to understand and willingness to sign a written informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carol Felix
Phone
310-825-9771
Email
cfelix@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Chin, MD
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Felix
Phone
310-825-9771
Email
cfelix@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Robert Chin

12. IPD Sharing Statement

Learn more about this trial

Stereotactic Body Radiation Therapy Using HyperArc in Treating Patients With Recurrent Head and Neck Cancer

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