Oropharynx CancerOPC-VNCT05849142
Feasibility of Adaptive Radiation Therapy for Human-papilloma Virus-positive Oropharyngeal Cancer Patients on MRIdian Linac
A study testing MRIdian Linac in people with Oropharynx Cancer, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research is to determine whether it is feasible to treat patients with Human Papilloma Virus positive (HPV-positive) oropharyngeal tumors on a specialized treatment machine (MRIdian linear accelerator [Linac]), which utilizes magnetic resonance imaging (MRI) for radiation planning and delivery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharynx Cancer
- What is being tested?
- MRIdian Linac
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 1 Dec 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
- Pathologically confirmed new diagnosis of HPV-positive OPC [i.e. Base of tongue, tonsil, soft palate, vallecula, and posterior pharyngeal wall]
- American Joint Committee on Cancer (AJCC) 8th edition Stage I-III planned for definitive chemoradiation.
- Members of all races and ethnic backgrounds
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for duration of study participation.
- Must be able to understand and sign an Institutional Review Board (IRB)-approved written informed consent document.
Who cannot join
- Prior surgery, chemotherapy, or radiation treatment for head and neck cancer
- Prior history of cancer other than non-melanomatous skin cancer
- Distant metastases (cM1) or (pM1) disease)
- Evidence of a compromised airway
- Medical contraindications to MRIs
- Unable to tolerate MRIs without sedation
Show all 9Show fewer
- Pregnant patients
- Breastfeeding patients
- Eastern Cooperative Oncology Group (ECOG) performance status >1
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
About this study
The purpose of this research is to determine whether it is feasible to treat patients with Human Papilloma Virus positive (HPV-positive) oropharyngeal tumors on a specialized treatment machine (MRIdian linear accelerator [Linac]), which utilizes magnetic resonance imaging (MRI) for radiation planning and delivery.
- Conditions
- Oropharynx Cancer
- Being tested
- MRIdian Linac
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIdian LinacDevice
Also called ViewRay
Radiation therapy (RT) will be delivered with an integrated MRI-RT delivery system (MRIdian Linac). Participants will then receive standard-of-care RT with a dose prescription of 70 Gy in 35 fractions on the MRIdian Linac. Adaptive RT (ART) planning will occur every 5th fraction of RT.
| Study group | Role | What they receive |
|---|---|---|
| MRIdian Linac Group | Experimental | All accrued participants will be enrolled onto the MRIdian Linac Group. Participants will receive adaptive radiotherapy (ART) on the MRIdian Linac. Participants will complete the duration of their radiotherapy regimen on the MRIdian Linac for approximately 7 weeks. Receives: Device: MRIdian Linac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent difference between initial reference plan and adaptive weekly RT plan
Weekly adaptive plans will be compared to the initial reference plan and compared using a percent difference equation estimating the actual values of the quantities used as dosimetric constraints for each participant between the initial reference plan and the weekly adaptive plan[s].
Measured: Up to 6 months
Evaluation of deformable imaging registration
For evaluation of deformable imaging registration, deformed contours will be compared to the physician-segmented contours using the Dice similarity coefficient (DSC).
Measured: Up to 6 months
Secondary outcomes (3)
Treatment times recorded in minutes
We will follow previously-established guidelines by the MR-Linac Consortium Head and Neck Tumor Site for measuring treatment times. Treatment times will be calculated in minutes from the time stamps in the record and verify system. Three timepoints will be recorded: [1] setup and plan optimization [i.e. time between the participant's arrival to the MRidian and delivery of the first beam]; [2] beam delivery [i.e. the time between delivery of the first and last beam]; and [3] total treatment time.
Measured: Up to 6 months
Patient-reported Quality of Life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30)
Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). It consists of 30 items to measure multiple aspects that incorporated five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale, and six single common items (dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties). The scoring system ranged from 1 (not at all) to 4 (very much). High scores for functional items and low scores for symptoms represent the good QoL.There are two questions for the overall quality of life rating, and the ranking ranged from 1 (very poor) to 7 (excellent).
Measured: Up to 1 year
Patient-reported Quality of Life as measured by the European Organization for Research and Treatment Head & Neck 43
Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-H\&N43). The questionnaire used will be for that for head and neck patients, score range from 1 (not at all) to 4 (very much), higher scores indicate lower quality of life.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Why it stopped: MRI Linac contract was not renewed at our institution after Viewray went bankrupt. Therefore we cannot do adaptive treatments on this machine. No patients were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Samuels, University of Miami
- Investigators
- Stuart Samuels, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849142
- Sponsor's protocol ID
- 20220776
- Acronym
- OPC-V
- Status last verified
- Sep 2024
- First submitted
- 25 Apr 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Adaptive Radiation Therapy for Human-papilloma Virus-positive Oropharyngeal Cancer Patients on MRIdian Linac
- ClinicalTrials.gov ID
- NCT05849142
- Acronym / sponsor ID
- OPC-V / 20220776
- Conditions
- Oropharynx Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: MRI Linac contract was not renewed at our institution after Viewray went bankrupt. Therefore we cannot do adaptive treatments on this machine. No patients were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 8 May 2023 (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 purpose of this research is to determine whether it is feasible to treat patients with Human Papilloma Virus positive (HPV-positive) oropharyngeal tumors on a specialized treatment machine (MRIdian linear accelerator [Linac]), which utilizes magnetic resonance imaging (MRI) for radiation planning and delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRIdian Linac Group | Experimental | Device: MRIdian LinacAll accrued participants will be enrolled onto the MRIdian Linac Group. Participants will receive adaptive radiotherapy (ART) on the MRIdian Linac. Participants will complete the duration of their radiotherapy regimen on the MRIdian Linac for approximately 7 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically confirmed new diagnosis of HPV-positive OPC [i.e. Base of tongue, tonsil, soft palate, vallecula, and posterior pharyngeal wall]
- American Joint Committee on Cancer (AJCC) 8th edition Stage I-III planned for definitive chemoradiation.
- Members of all races and ethnic backgrounds
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for duration of study participation.
- Must be able to understand and sign an Institutional Review Board (IRB)-approved written informed consent document.
Key exclusion criteria (9 listed)
- Prior surgery, chemotherapy, or radiation treatment for head and neck cancer
- Prior history of cancer other than non-melanomatous skin cancer
- Distant metastases (cM1) or (pM1) disease)
- Evidence of a compromised airway
- Medical contraindications to MRIs
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 |
|---|---|---|
| MRIdian LinacAlso: ViewRayRadiation therapy (RT) will be delivered with an integrated MRI-RT delivery system (MRIdian Linac). Participants will then receive standard-of-care RT with a dose prescription of 70 Gy in 35 fractions on the MRIdian Linac. Adaptive RT (ART) planning will occur every 5th fraction of RT. | Device | MRIdian Linac Group |
Primary outcome
Percent difference between initial reference plan and adaptive weekly RT plan
Time frame: Up to 6 months
Weekly adaptive plans will be compared to the initial reference plan and compared using a percent difference equation estimating the actual values of the quantities used as dosimetric constraints for each participant between the initial reference plan and the weekly adaptive plan[s].
Evaluation of deformable imaging registration
Time frame: Up to 6 months
For evaluation of deformable imaging registration, deformed contours will be compared to the physician-segmented contours using the Dice similarity coefficient (DSC).
3 secondary outcomes
Treatment times recorded in minutes
Time frame: Up to 6 months
Patient-reported Quality of Life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30)
Time frame: Up to 1 year
Patient-reported Quality of Life as measured by the European Organization for Research and Treatment Head & Neck 43
Time frame: Up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Stuart Samuels, MD, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRIdian Linac in people with Oropharynx Cancer, run by University of Miami 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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 19 Sep 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 was withdrawn before enrolling participants, so there are no results.
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?
Percent difference between initial reference plan and adaptive weekly RT plan (time frame: Up to 6 months). 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 19 Sep 2024.