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

Jonsson Comprehensive Cancer Center

Status: Completed

Conditions: Recurrent Head and Neck Carcinoma

Treatments: Radiation: Stereotactic Body Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03892720

18-001247 (Other Identifier)

NCI-2018-02996 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Treatment (SBRT)

Experimental group

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.

Treatment:

Other: Questionnaire Administration

Radiation: Stereotactic Body Radiation Therapy

Other: Quality-of-Life Assessment