Clinical trial NCT03892720: 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
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Head and Neck Carcinoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Varian, a Siemens Healthineers Company
First posted: 2019-03-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: At 1 year
measure: Percent of patients with acute or chronic grade >= 3 treatment-related toxicity per Common Terminology Criteria for Adverse Events version 4.0
timeFrame: At 1 year
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: The time between the first dose of stereotactic body radiation therapy (SBRT) and death, assessed at 1 year
measure: OS
timeFrame: The time between the first dose of SBRT and death, assessed at 2 years
measure: Median OS
timeFrame: The time between the first dose of SBRT and death, assessed up to 2 years
measure: Progression-free survival (PFS)
timeFrame: From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed at 1 year
measure: PFS
timeFrame: From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed at 2 years
measure: Median PFS
timeFrame: From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed up to 2 years
measure: Locoregional progression-free survival (LPFS)
timeFrame: 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
measure: LPFS
timeFrame: 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
measure: Median LPFS
timeFrame: 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 outcomes:
measure: Dosimetric data including achievable dose to target and organs at risk (OAR)
timeFrame: Up to 2 years
measure: Serum markers predictive of response and/or toxicity
timeFrame: Up to 2 years
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Robert Chin, MD
role: PRINCIPAL_INVESTIGATOR
References: