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

NCT03892720 | Completed DMC FDA Device

• 2 other identifiers: 18-001247NCI-2018-02996
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• Overall survival (OS)

  The time between the first dose of stereotactic body radiation therapy (SBRT) and death, assessed at 1 year

• OS

  The time between the first dose of SBRT and death, assessed at 2 years

• Median OS

  The time between the first dose of SBRT and death, assessed up to 2 years

• Progression-free survival (PFS)

  From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed at 1 year

• PFS

  From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed at 2 years

Other Outcomes (2)

• Dosimetric data including achievable dose to target and organs at risk (OAR)

  Up to 2 years

• Serum markers predictive of response and/or toxicity

  Up to 2 years

Study Arms (1)

Treatment (SBRT)

EXPERIMENTAL

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; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (SBRT)

Questionnaire Administration OTHER

Ancillary studies

Treatment (SBRT)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Treatment (SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Varian, a Siemens Healthineers Company: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Robert Chin, MD

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 27, 2019
• Study Start: March 27, 2019
• Primary Completion: August 21, 2024
• Study Completion: August 21, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

US (1)