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Completed

NCT Number: NCT03892720

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Stereotactic Body Radiation Therapy

Radiation

Undergo SBRT

Other names: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • Varian, a Siemens Healthineers Company

Registry information

Official study title

A Phase II Study of Non-Coplanar SBRT Re-Irradiation Using HyperArc in Patients With Recurrent Head and Neck Cancer

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2019
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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