Oropharyngeal Squamous Cell Carcinoma (OPSCCA)NCT01891695
OPSCC N0 Nodal Control With Reduced IMRT
A study testing 39.6 Gy radiation in people with Oropharyngeal Squamous Cell Carcinoma (OPSCCA) and HPV (Human Papillomavirus)-Associated, run by Paul W. Read, MD at 1 site in United States.
Trial summary
The dose of radiation most commonly used to treat oropharyngeal cancer results in side effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered taste, swallowing problems including pain or inability to swallow requiring feeding tubes to be placed in the stomach, hoarseness or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma (OPSCCA), HPV (Human Papillomavirus)-Associated
- What is being tested?
- 39.6 Gy radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- patient must be clinically referred for radiation for stage I-IVb OPSCCA
- tumor must be HPV-associated p16+
- patient must be able to lie flat and tolerate immobilization systems
Who cannot join
- patients may not be receiving any investigational agents
- prior radiation to head and neck
- any other malignancy except non-melanomatous skin cancer or a carcinoma not of head and neck origin with patient being disease free for at least 5 years
- any major medical, psychiatric, or neurologic illness
- pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Official title: A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx
The dose of radiation most commonly used to treat oropharyngeal cancer results in side effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered taste, swallowing problems including pain or inability to swallow requiring feeding tubes to be placed in the stomach, hoarseness or breathing problems from swelling requiring tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe, nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear drums in the middle ear, skin redness tenderness and blistering.
The purpose of this study is to determine if the investigators can reduce the dose of radiation to the lymph nodes in the neck that may contain cancer cells that are not detected by physical examinations or radiologic studies (CT scans, PET CT scans, or MRI scans) in order to reduce the side effects from treatment and still adequately kill any cancer cells that may be contained in those lymph nodes.
Read the detailed description
A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx.
- Being tested
- 39.6 Gy radiation
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
39.6 Gy radiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Reduced Intensity Radiation | Experimental | 39.6 Gy radiation to clinically uninvolved cervical lymphatics Receives: Radiation: 39.6 Gy radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
N0 Nodal Control Rate
Effectiveness of 39.6 Gy (Gray) radiation on tumor control in the clinically uninvolved (N0) cervical lymphatics of patients with p16+ oropharyngeal squamous cell carcinoma (OPSCCA)
Measured: Up to 3 years post treatment
Secondary outcomes (3)
Adverse Events of Participants Treated With 39.6 Gy Radiation to the Clinically Uninvolved Neck
Evaluated safety and tolerability of treatment of p16+ OPSCCA by overall incidence of adverse events, incidence of acute and late toxicities and subject-rated quality of life assessments.
Measured: Up to 3 years post treatment
Progression Free Survival Following 39.6 Gy Radiation to the Clinically Uninvolved Neck
Patient status reviewed and confirmed through Neck CT and PET scans at follow up time points throughout trial
Measured: Up to 3 years post treatment
Dose Volume Histograms (DVH)
Comparison of DVH of treatment plans between patients receiving 39.6 Gy versus the standard dose of 50 Gy to the clinically uninvolved neck
Measured: Up to 3 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2016
- Study completionDec 2016
Why it stopped: Study had very specific inclusion/exclusion criteria and difficult to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oropharyngeal Squamous Cell Carcinoma (OPSCCA)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul W. Read, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul W. Read, MD, University of Virginia
- Investigators
- Paul W Read, MD, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891695
- Sponsor's protocol ID
- 16766
- Status last verified
- Sep 2022
- First submitted
- 24 Jun 2013
- Last updated
- 12 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx
- ClinicalTrials.gov ID
- NCT01891695
- Acronym / sponsor ID
- 16766
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study had very specific inclusion/exclusion criteria and difficult to recruit
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Paul W. Read, MDUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Posted 12 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The dose of radiation most commonly used to treat oropharyngeal cancer results in side effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered taste, swallowing problems including pain or inability to swallow requiring feeding tubes to be placed in the stomach, hoarseness or breathing problems from swelling requiring tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe, nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear drums in the middle ear, skin redness tenderness and blistering.
The purpose of this study is to determine if the investigators can reduce the dose of radiation to the lymph nodes in the neck that may contain cancer cells that are not detected by physical examinations or radiologic studies (CT scans, PET CT scans, or MRI scans) in order to reduce the side effects from treatment and still adequately kill any cancer cells that may be contained in those lymph nodes.
Detailed description
A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reduced Intensity Radiation | Experimental | Radiation: 39.6 Gy radiation39.6 Gy radiation to clinically uninvolved cervical lymphatics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient must be clinically referred for radiation for stage I-IVb OPSCCA
- tumor must be HPV-associated p16+
- patient must be able to lie flat and tolerate immobilization systems
Key exclusion criteria (5 listed)
- patients may not be receiving any investigational agents
- prior radiation to head and neck
- any other malignancy except non-melanomatous skin cancer or a carcinoma not of head and neck origin with patient being disease free for at least 5 years
- any major medical, psychiatric, or neurologic illness
- pregnant or breastfeeding women
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 |
|---|---|---|
| 39.6 Gy radiation | Radiation | Reduced Intensity Radiation |
Primary outcome
N0 Nodal Control Rate
Time frame: Up to 3 years post treatment
Effectiveness of 39.6 Gy (Gray) radiation on tumor control in the clinically uninvolved (N0) cervical lymphatics of patients with p16+ oropharyngeal squamous cell carcinoma (OPSCCA)
3 secondary outcomes
Adverse Events of Participants Treated With 39.6 Gy Radiation to the Clinically Uninvolved Neck
Time frame: Up to 3 years post treatment
Progression Free Survival Following 39.6 Gy Radiation to the Clinically Uninvolved Neck
Time frame: Up to 3 years post treatment
Dose Volume Histograms (DVH)
Time frame: Up to 3 years post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Oropharyngeal Squamous Cell Carcinoma (OPSCCA)
Not yet recruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 1
Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery
Oropharyngeal Squamous Cell Carcinoma (OPSCCA), Oropharyngeal Cancer
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.
Paul W Read, MD, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 39.6 Gy radiation in people with Oropharyngeal Squamous Cell Carcinoma (OPSCCA) and HPV (Human Papillomavirus)-Associated, run by Paul W. Read, MD 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 5 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: stopped early, as of the sponsor's last update on 12 Oct 2022. 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?
Yes. Results are posted in the registry (first posted 12 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
N0 Nodal Control Rate (time frame: Up to 3 years post treatment). 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 12 Oct 2022.