Head and Neck CancerPEAQ-RTNCT04379505
Palliative Expeditiously Adaptive Quad Shot Radiation Therapy (PEAQ-RT)
A study testing Ring gantry kV-CBCT combined with linear accelerator (Halcyon) and Quad shot radiation in people with Head and Neck Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators propose evaluating the feasibility of using the novel cone beam computed tomography (CBCT)-guided Ethos system to deliver expedited, adaptive Quad shot radiation for the purpose of palliative radiation of patients with advanced head and neck cancers or patients with a history of any malignancy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Ring gantry kV-CBCT combined with linear accelerator (Halcyon) and Quad shot radiation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 5 Dec 2023
- 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
- History of a head and neck malignancy or history of any malignancy experiencing current head and neck lesions suitable for radiation. Past history of radiotherapy is allowed for inclusion and brain metastases are allowed for inclusion.
- Deemed medically fit for Quad shot radiation by treating physician
- At least 18 years of age.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- -Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol PI, documentation of this exception is sufficient in lieu of pregnancy test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Palliative Expeditiously Adaptive Quad Shot Radiation Therapy (PEAQ-RT): A Pilot Study of Consolidated Simulation and Target Identification of Quad Shot Radiation Therapy Using an Adaptive Radiotherapy Workflow With a Novel Ring Gantry Radiotherapy Device
The investigators propose evaluating the feasibility of using the novel cone beam computed tomography (CBCT)-guided Ethos system to deliver expedited, adaptive Quad shot radiation for the purpose of palliative radiation of patients with advanced head and neck cancers or patients with a history of any malignancy experiencing current head and neck lesions. Quad shot radiation was selected as the palliative regimen of choice given its low toxicity profile, well published efficacy in palliation, frequent usage in the US for palliation of head and neck cancers, and safety in the setting of re-irradiation. The use of the Ethos platform to perform online adaptive radiation planning and delivery remains novel and untested. The Ethos system would be used to consolidate CT simulation, replanning, and treatment for Quad shot patients receiving treatment with the benefit of reduced patient travel and a reduction in the unwanted delay between Quad shot cycles. The goal of this pilot study will be to evaluate the feasibility of the Ethos system to eliminate the need for a CT simulation for cycles 2 and 3 of Quad shot radiation.
- Conditions
- Head and Neck Cancer
- Being tested
- Ring gantry kV-CBCT combined with linear accelerator (Halcyon), Quad shot radiation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ring gantry kV-CBCT combined with linear accelerator (Halcyon)Device
-Varian Medical Systems is the manufacturer
Quad shot radiationRadiation
Treatment of each cycle should ideally take place on two consecutive days. Allowing for holidays, weekends, and other scheduling issues or unexpected delays, treatment may be completed within five calendar days.
| Study group | Role | What they receive |
|---|---|---|
| Quad shot radiation | Experimental | -Radiotherapy will consist of Quad shot radiation delivered on the Ethos ring gantry kV-CBCT combined with linear accelerator system to a dose of 14 Gy in four, twice-daily fractions of 3.5 Gy delivered at least 6 hours apart over two days for a possible total of 3 cycles delivered in 3 to 4 intervals for a cumulative dose of of 42 Gy in 12 fractions. Cycle 2 and 3 of treatment is not mandated per protocol but may be given at the discretion of the treating physician. Receives: Device: Ring gantry kV-CBCT combined with linear accelerator (Halcyon); Radiation: Quad shot radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by the successful completion of Quad shot radiation using CBCT instead of routine CT simulation in 80% of attempted simulated patients
Measured: Completion of treatment by all patients enrolled (estimated to be 3 years and 12 weeks)
Secondary outcomes (2)
Average time (days) required from initial consult to completion of radiation therapy for patient travel and visits to the department
Measured: Approximately 12 weeks
Percentage of patients from whom repeat CT simulation was eliminated
Measured: Completion of treatment by all patients enrolled (estimated to be 3 years and 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Oct 2020
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Wade Thorstad, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379505
- Sponsor's protocol ID
- 202004210
- Acronym
- PEAQ-RT
- Status last verified
- Dec 2023
- First submitted
- 4 May 2020
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The investigators will provide a summary of basic outcomes and clinical results within one year.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Expeditiously Adaptive Quad Shot Radiation Therapy (PEAQ-RT): A Pilot Study of Consolidated Simulation and Target Identification of Quad Shot Radiation Therapy Using an Adaptive Radiotherapy Workflow With a Novel Ring Gantry Radiotherapy Device
- ClinicalTrials.gov ID
- NCT04379505
- Acronym / sponsor ID
- PEAQ-RT / 202004210
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 7 May 2020 (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.
The investigators propose evaluating the feasibility of using the novel cone beam computed tomography (CBCT)-guided Ethos system to deliver expedited, adaptive Quad shot radiation for the purpose of palliative radiation of patients with advanced head and neck cancers or patients with a history of any malignancy experiencing current head and neck lesions. Quad shot radiation was selected as the palliative regimen of choice given its low toxicity profile, well published efficacy in palliation, frequent usage in the US for palliation of head and neck cancers, and safety in the setting of re-irradiation. The use of the Ethos platform to perform online adaptive radiation planning and delivery remains novel and untested. The Ethos system would be used to consolidate CT simulation, replanning, and treatment for Quad shot patients receiving treatment with the benefit of reduced patient travel and a reduction in the unwanted delay between Quad shot cycles. The goal of this pilot study will be to evaluate the feasibility of the Ethos system to eliminate the need for a CT simulation for cycles 2 and 3 of Quad shot radiation.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quad shot radiation | Experimental | Device: Ring gantry kV-CBCT combined with linear accelerator (Halcyon), Radiation: Quad shot radiation-Radiotherapy will consist of Quad shot radiation delivered on the Ethos ring gantry kV-CBCT combined with linear accelerator system to a dose of 14 Gy in four, twice-daily fractions of 3.5 Gy delivered at least 6 hours apart over two days for a possible total of 3 cycles delivered in 3 to 4 intervals for a cumulative dose of of 42 Gy in 12 fractions. Cycle 2 and 3 of treatment is not mandated per protocol but may be given at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of a head and neck malignancy or history of any malignancy experiencing current head and neck lesions suitable for radiation. Past history of radiotherapy is allowed for inclusion and brain metastases are allowed for inclusion.
- Deemed medically fit for Quad shot radiation by treating physician
- At least 18 years of age.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Key exclusion criteria (1 listed)
- -Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol PI, documentation of this exception is sufficient in lieu of pregnancy test.
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 |
|---|---|---|
| Ring gantry kV-CBCT combined with linear accelerator (Halcyon)-Varian Medical Systems is the manufacturer | Device | Quad shot radiation |
| Quad shot radiationTreatment of each cycle should ideally take place on two consecutive days. Allowing for holidays, weekends, and other scheduling issues or unexpected delays, treatment may be completed within five calendar days. | Radiation | Quad shot radiation |
Primary outcome
Feasibility as measured by the successful completion of Quad shot radiation using CBCT instead of routine CT simulation in 80% of attempted simulated patients
Time frame: Completion of treatment by all patients enrolled (estimated to be 3 years and 12 weeks)
2 secondary outcomes
Average time (days) required from initial consult to completion of radiation therapy for patient travel and visits to the department
Time frame: Approximately 12 weeks
Percentage of patients from whom repeat CT simulation was eliminated
Time frame: Completion of treatment by all patients enrolled (estimated to be 3 years and 12 weeks)
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 8 Dec 2023.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The investigators will provide a summary of basic outcomes and clinical results within one year.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Wade Thorstad, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ring gantry kV-CBCT combined with linear accelerator (Halcyon) and Quad shot radiation in people with Head and Neck Cancer, run by Washington University School of Medicine 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 4 inclusion and 1 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 8 Dec 2023. 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?
Feasibility as measured by the successful completion of Quad shot radiation using CBCT instead of routine CT simulation in 80% of attempted simulated patients (time frame: Completion of treatment by all patients enrolled (estimated to be 3 years and 12 weeks)). 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 8 Dec 2023.