Recurrent Head and Neck CarcinomaNCT03892720
Stereotactic Body Radiation Therapy Using HyperArc in Treating Patients With Recurrent Head and Neck Cancer
A study testing Quality-of-Life Assessment, Questionnaire Administration and Stereotactic Body Radiation Therapy in people with Recurrent Head and Neck Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Head and Neck Carcinoma
- What is being tested?
- Quality-of-Life Assessment, Questionnaire Administration and Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2019to 21 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: A Phase II Study of Non-Coplanar SBRT Re-Irradiation Using HyperArc in 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
- Conditions
- Recurrent Head and Neck Carcinoma
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration, Stereotactic Body Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 1 year
Secondary outcomes (9)
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.
Measured: The time between the first dose of stereotactic body radiation therapy (SBRT) and death, assessed at 1 year
OS
The Kaplan-Meier method will be used to provide an estimate of OS. The corresponding 95% confidence interval will also be presented.
Measured: The time between the first dose of SBRT and death, assessed at 2 years
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.
Measured: The time between the first dose of SBRT and death, assessed up to 2 years
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.
Measured: From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed at 1 year
PFS
The Kaplan-Meier method will be used to provide an estimate of PFS. The corresponding 95% confidence interval will also be presented.
Measured: From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed at 2 years
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.
Measured: From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed up to 2 years
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.
Measured: 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
LPFS
The Kaplan-Meier method will be used to provide an estimate of LPFS. The corresponding 95% confidence interval will also be presented.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start27 Mar 2019
- Primary completion21 Aug 2024
- Study completion21 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Varian, a Siemens Healthineers Company
- Responsible party
- Sponsor
- Investigators
- Robert Chin, MD, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892720
- Sponsor's protocol ID
- 18-001247
- Other IDs
- NCI-2018-02996
- Status last verified
- Aug 2024
- First submitted
- 26 Mar 2019
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Non-Coplanar SBRT Re-Irradiation Using HyperArc in Patients With Recurrent Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03892720
- Acronym / sponsor ID
- 18-001247
- Conditions
- Recurrent Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Varian, a Siemens Healthineers Company
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SBRT) | Experimental | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Stereotactic Body Radiation TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (SBRT) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (SBRT) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Treatment (SBRT) |
Primary outcome
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.
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.
9 secondary outcomes
Overall survival (OS)
Time frame: The time between the first dose of stereotactic body radiation therapy (SBRT) and death, assessed at 1 year
OS
Time frame: The time between the first dose of SBRT and death, assessed at 2 years
Median OS
Time frame: The time between the first dose of SBRT and death, assessed up to 2 years
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Chin, MD principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality-of-Life Assessment, Questionnaire Administration and Stereotactic Body Radiation Therapy in people with Recurrent Head and Neck Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: At 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.