Head and Neck NeoplasmsNCT04782726
Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution
A study testing Software Solution for Radiation Therapy Treatment and Radiation therapy in people with Head and Neck Neoplasms, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The researchers hope that based on the study findings future patients may benefit from a more precise radiation treatment plan that can be developed more quickly and thus decrease the time from Computerized Tomography Simulation to start of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Software Solution for Radiation Therapy Treatment and Radiation therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2021to 20 Jan 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
- Age ≥ 18 years.
- Ability to provide informed written consent in either English or Spanish.
- Patient planned to undergo radiation therapy for Head and Neck Cancer.
Who cannot join
- Current pregnancy, as this is a contraindication to receiving radiation therapy.
- History of prior radiotherapy to the head and neck.
- Any condition or history as evidenced by patient record and/or self-report that, in the opinion of the investigator, would interfere with adherence to daily radiation therapy.
Trial locations and contacts
1 site in 1 country.
About this study
The researchers hope that based on the study findings future patients may benefit from a more precise radiation treatment plan that can be developed more quickly and thus decrease the time from Computerized Tomography Simulation to start of treatment.
Read the detailed description
As part of this study participants will receive the standard of care treatment for all head and neck cancer patients. The researchers plan to use a software program to see if it will assist in developing the best radiation treatment plan possible. The researchers will also measure the quality of each treatment plan so areas of improvement can be identified.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Software Solution for Radiation Therapy Treatment, Radiation therapy
- 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.
Software Solution for Radiation Therapy TreatmentOther
Also called Treatment planning
Software has been developed for individualized pre optimization evaluation of the patient anatomy and prescribed dose of radiation therapy.
Radiation therapyOther
Also called Radiation treatment
Standard of Care planning for Radiation therapy is used to treat the subjects for head and neck cancer
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | After consent and study enrollment the subject will be scheduled for CT simulation for radiation treatment planning. At the time of CT simulation, they will be immobilized by means of a thermoplastic mask. For patients in the control arm, the radiation treatment planning will proceed as normal. Treatment planning is performed on Pinnacle. The patient will return for validation of the radiation plan. Validation involves collecting on-table X-rays or cone beam CTs when the patient is in position for treatment, which is the standard of care. Most often, the date of validation will happen within 5 business days of the CT simulation. Receives: Other: Radiation therapy |
| Research Arm | Experimental | After consent and study enrollment the subject will be scheduled for CT simulation for radiation treatment planning. At the time of CT simulation, they will be immobilized by means of a thermoplastic mask. For patients in the research arm, a theoretical plan will be created after physician's segmentation and will be used as a guide for the final plan. The patient will return for validation of the radiation plan. Validation involves collecting on-table X-rays or cone beam CTs when the patient is in position for treatment, which is the standard of care. Most often, the date of validation will happen within 5 business days of the CT simulation. Receives: Other: Software Solution for Radiation Therapy Treatment; Other: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean radiation dose to Organs at Risk (OAR)
Measurement of radiation dose to organs at risk. The goal is to maintain the PTV (Planning Target Volume) coverage while minimizing the dose to organs at risk (OARs).
Measured: Baseline to last treatment (up to 33 treatments or about 7 weeks)
Maximum radiation dose to Organs at Risk (OAR)
Measurement of maximum radiation dose to organs at risk. The goal is to maintain the PTV (Planning Target Volume) coverage while minimizing the dose to organs at risk (OARs).
Measured: Baseline to last treatment (up to 33 treatments or about 7 weeks)
Secondary outcomes (1)
Time required to plan radiation therapy dose
The time required with and without individualized pre optimization information will be recorded and compared to determine efficiency.
Measured: CT Simulation to first treatment (about 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start16 Dec 2021
- Primary completion20 Jan 2023
- Study completion20 Jan 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 NeoplasmsStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sotirios Stathakis, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782726
- Sponsor's protocol ID
- CTMS# 20-0114
- Other IDs
- HSC20200678H
- Status last verified
- Jan 2023
- First submitted
- 1 Mar 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution
- ClinicalTrials.gov ID
- NCT04782726
- Acronym / sponsor ID
- CTMS# 20-0114
- Conditions
- Head and Neck Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 4 Mar 2021 (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 researchers hope that based on the study findings future patients may benefit from a more precise radiation treatment plan that can be developed more quickly and thus decrease the time from Computerized Tomography Simulation to start of treatment.
Detailed description
As part of this study participants will receive the standard of care treatment for all head and neck cancer patients. The researchers plan to use a software program to see if it will assist in developing the best radiation treatment plan possible. The researchers will also measure the quality of each treatment plan so areas of improvement can be identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Other: Radiation therapyAfter consent and study enrollment the subject will be scheduled for CT simulation for radiation treatment planning. At the time of CT simulation, they will be immobilized by means of a thermoplastic mask. For patients in the control arm, the radiation treatment planning will proceed as normal. Treatment planning is performed on Pinnacle. The patient will return for validation of the radiation plan. Validation involves collecting on-table X-rays or cone beam CTs when the patient is in position for treatment, which is the standard of care. Most often, the date of validation will happen within 5 business days of the CT simulation. |
| Research Arm | Experimental | Other: Software Solution for Radiation Therapy Treatment, Other: Radiation therapyAfter consent and study enrollment the subject will be scheduled for CT simulation for radiation treatment planning. At the time of CT simulation, they will be immobilized by means of a thermoplastic mask. For patients in the research arm, a theoretical plan will be created after physician's segmentation and will be used as a guide for the final plan. The patient will return for validation of the radiation plan. Validation involves collecting on-table X-rays or cone beam CTs when the patient is in position for treatment, which is the standard of care. Most often, the date of validation will happen within 5 business days of the CT simulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Ability to provide informed written consent in either English or Spanish.
- Patient planned to undergo radiation therapy for Head and Neck Cancer.
Key exclusion criteria (3 listed)
- Current pregnancy, as this is a contraindication to receiving radiation therapy.
- History of prior radiotherapy to the head and neck.
- Any condition or history as evidenced by patient record and/or self-report that, in the opinion of the investigator, would interfere with adherence to daily radiation therapy.
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 |
|---|---|---|
| Software Solution for Radiation Therapy TreatmentAlso: Treatment planningSoftware has been developed for individualized pre optimization evaluation of the patient anatomy and prescribed dose of radiation therapy. | Other | Research Arm |
| Radiation therapyAlso: Radiation treatmentStandard of Care planning for Radiation therapy is used to treat the subjects for head and neck cancer | Other | Control Arm, Research Arm |
Primary outcome
Mean radiation dose to Organs at Risk (OAR)
Time frame: Baseline to last treatment (up to 33 treatments or about 7 weeks)
Measurement of radiation dose to organs at risk. The goal is to maintain the PTV (Planning Target Volume) coverage while minimizing the dose to organs at risk (OARs).
Maximum radiation dose to Organs at Risk (OAR)
Time frame: Baseline to last treatment (up to 33 treatments or about 7 weeks)
Measurement of maximum radiation dose to organs at risk. The goal is to maintain the PTV (Planning Target Volume) coverage while minimizing the dose to organs at risk (OARs).
1 secondary outcome
Time required to plan radiation therapy dose
Time frame: CT Simulation to first treatment (about 1 week)
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 25 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Sotirios Stathakis, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Software Solution for Radiation Therapy Treatment and Radiation therapy in people with Head and Neck Neoplasms, run by The University of Texas Health Science Center at San Antonio 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 3 inclusion and 3 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 25 Jan 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. Some participants in this study may receive a placebo. 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?
Mean radiation dose to Organs at Risk (OAR) (time frame: Baseline to last treatment (up to 33 treatments or about 7 weeks)). 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 25 Jan 2023.