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

Recurrent Head and Neck Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03892720
• Other study ID #: 18-001247
• Secondary ID: NCI-2018-02996
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 27, 2019
• Est. completion date: April 1, 2026

Study information

• Verified date: April 2024
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Recurrence
• Recurrent Head and Neck Carcinoma

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Radiation:
• Stereotactic Body Radiation Therapy
Undergo SBRT

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Varian, a Siemens Healthineers Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dosimetric data including achievable dose to target and organs at risk (OAR)	Data will be collected but not analyzed.	Up to 2 years
Other	Serum markers predictive of response and/or toxicity	Will perform correlation analysis to explore serum markers predictive of efficacy endpoints.	Up to 2 years
Primary	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.	At 1 year
Primary	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.	At 1 year
Secondary	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.	The time between the first dose of stereotactic body radiation therapy (SBRT) and death, assessed at 1 year
Secondary	OS	The Kaplan-Meier method will be used to provide an estimate of OS. The corresponding 95% confidence interval will also be presented.	The time between the first dose of SBRT and death, assessed at 2 years
Secondary	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.	The time between the first dose of SBRT and death, assessed up to 2 years
Secondary	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.	From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed at 1 year
Secondary	PFS	The Kaplan-Meier method will be used to provide an estimate of PFS. The corresponding 95% confidence interval will also be presented.	From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed at 2 years
Secondary	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.	From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed up to 2 years
Secondary	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.	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
Secondary	LPFS	The Kaplan-Meier method will be used to provide an estimate of LPFS. The corresponding 95% confidence interval will also be presented.	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
Secondary	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.	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