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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03892720
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : January 19, 2023
Sponsor:
Collaborator:
Varian, a Siemens Healthineers Company
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recurrent Head and Neck Carcinoma Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Stereotactic Body Radiation Therapy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Non-Coplanar SBRT Re-Irradiation Using HyperArc in Patients With Recurrent Head and Neck Cancer
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (SBRT)
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.
 Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: At 1 year ]
    Will calculate the percentage and construct 95% exact confidence interval for local control rate.

  2. Percent of patients with acute or chronic grade >= 3 treatment-related toxicity per Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: At 1 year ]
    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 :
  1. Overall survival (OS) [ Time Frame: The time between the first dose of stereotactic body radiation therapy (SBRT) and death, assessed at 1 year ]
    The Kaplan-Meier method will be used to provide an estimate of OS. The corresponding 95% confidence interval will also be presented.

  2. OS [ Time Frame: The time between the first dose of SBRT and death, assessed at 2 years ]
    The Kaplan-Meier method will be used to provide an estimate of OS. The corresponding 95% confidence interval will also be presented.

  3. Median OS [ Time Frame: The time between the first dose of SBRT and death, assessed up to 2 years ]
    The Kaplan-Meier method will be used to provide an estimate of median OS. The corresponding 95% confidence interval will also be presented.

  4. Progression-free survival (PFS) [ 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 ]
    The Kaplan-Meier method will be used to provide an estimate of PFS. The corresponding 95% confidence interval will also be presented.

  5. PFS [ 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 ]
    The Kaplan-Meier method will be used to provide an estimate of PFS. The corresponding 95% confidence interval will also be presented.

  6. Median PFS [ 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 ]
    The Kaplan-Meier method will be used to provide an estimate of median PFS. The corresponding 95% confidence interval will also be presented.

  7. Locoregional progression-free survival (LPFS) [ 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 ]
    The Kaplan-Meier method will be used to provide an estimate of LPFS. The corresponding 95% confidence interval will also be presented.

  8. LPFS [ 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 ]
    The Kaplan-Meier method will be used to provide an estimate of LPFS. The corresponding 95% confidence interval will also be presented.

  9. Median LPFS [ 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 ]
    The Kaplan-Meier method will be used to provide an estimate of median LPFS. The corresponding 95% confidence interval will also be presented.


Other Outcome Measures:
  1. Dosimetric data including achievable dose to target and organs at risk (OAR) [ Time Frame: Up to 2 years ]
    Data will be collected but not analyzed.

  2. Serum markers predictive of response and/or toxicity [ Time Frame: Up to 2 years ]
    Will perform correlation analysis to explore serum markers predictive of efficacy endpoints.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892720


Contacts
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Contact: Carol Felix 310-825-9771 cfelix@mednet.ucla.edu

Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Carol Felix    310-825-9771    cfelix@mednet.ucla.edu   
Principal Investigator: Robert Chin         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Varian, a Siemens Healthineers Company
Investigators
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Principal Investigator: Robert Chin, MD UCLA / Jonsson Comprehensive Cancer Center
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03892720    
Other Study ID Numbers: 18-001247
NCI-2018-02996 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: March 2022

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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
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Recurrence
Disease Attributes
 Pathologic Processes
Neoplasms by Site
Neoplasms