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Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8NCT04140513

Digital PET Scan for the Prediction of Outcomes in Patients With Locally Advanced Oropharyngeal Cancer

A study testing Fludeoxyglucose F-18 and Positron Emission Tomography in people with Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This trial studies how well digital PET scan works in predicting outcomes in patients with oropharyngeal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fludeoxyglucose F-18 and Positron Emission Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
9 Oct 2020to 1 Nov 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

  • Patient who will undergo definitive radiation with concurrent chemotherapy with cisplatin 40 mg/m^2 weekly (preferred) or high dose cisplatin 100 mg/m^2 for histologically confirmed locally advanced squamous cell carcinoma of the oropharynx
  • Patient must have clinically or radiographically evident measurable disease at the primary site and at nodal station(s). Tonsillectomy or local excision of the primary or nodal disease is not permitted
  • p16 and/or human papillomavirus (HPV) status obtained on biopsy specimen (archival or fresh)
  • Patients must provide their personal smoking history prior to registration
  • Patients must fall into one of the following stage (American Joint Committee on Cancer [AJCC] 8) and risk groups based on pre-treatment work-up and smoking history:
  • Low risk classification:
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  • p16 and/or HPV positive, T1-3, N1-2, M0 with =< 10 pack years smoking history OR
  • Intermediate risk classification:
  • p16 and/or HPV positive, T4, N3, M0 and/or HPV positive with > 10 pack year smoking history
  • HPV negative, T1-3, N1-2b, M0, with =< 10 pack years smoking history OR
  • High risk classification:
  • p16 and/or HPV negative, T4, N3, M0
  • p16 and/or HPV negative with > 10 pack year smoking history
  • Patients with no contraindications to PET imaging or cisplatin
  • No prior history of radiation therapy
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patients with remaining teeth must undergo a dental evaluation prior to enrolment
  • Ability to provide informed consent obtained prior to participation in the study and any related procedures being performed
  • Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the first administration of study treatment. Urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment
  • Women of child-bearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until 60 days following the last study treatment

Who cannot join

  • Prior cancers except non-melanoma skin cancer outside of the head and neck unless disease free for 5 years
  • Carcinoma of unknown primary, even if p16 positive
  • Clinical or radiologic evidence of metastatic disease as defined by disease below the clavicles
  • Simultaneous primary cancers or separate bilateral primary tumor sites with the exception of patients with bilateral tonsil cancers
  • Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Medical contraindications to PET imaging (e.g. pregnancy, nursing mothers, weight greater than 420 pounds)
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  • Medical contraindications to cisplatin or prior allergic reaction to cisplatin
  • Subjects who are unable to receive intravenous contrast due to a contrast allergy or poor renal function
  • Subjects who are prisoners
  • Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject?s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator. This could include severe, active co-morbidities such as:
  • Uncontrolled cardiac disease (hypertension, unstable angina, myocardial infarction within last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction)
  • Uncontrolled diabetes
  • Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Pilot Study to Evaluate the Utility of Interim Digital PET/CT in Predicting Outcomes for Locally Advanced Oropharyngeal Cancer

This trial studies how well digital PET scan works in predicting outcomes in patients with oropharyngeal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). The development of digital detectors for PET is a technological improvement in medical imaging that could potentially impact many areas of clinical oncology, including staging, radiation planning accuracy, and the assessment of treatment response. Digital technology may improve PET imaging performance by providing better timing, energy and spatial resolution, higher count rate capabilities and linearity, increased contrast, and reduced noise. Utilizing digital PET scan, may work better in predicting outcomes and treatment response in patients with oropharyngeal cancer compared to conventional PET.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the utility of early (i.e. during treatment) digital positron emission tomography (dPET) as a diagnostic tool to predict local control 6 months after definitive chemoradiation for patients with locally advanced oropharyngeal carcinoma.

SECONDARY OBJECTIVES:

  1. To study the association between dynamic dPET parameters taken at early time points (i.e. during treatment) and CR on PET after definitive chemoradiation.

II. To study the association between dynamic dPET parameters taken at early time points (i.e. during) treatment and 2 year local control after definitive chemoradiation.

III. To assess the ability of dynamic dPET compared to conventional PET or conventional-equivalent dPET reconstruction to identify tumor volumes with greater sensitivity at the time of before (dPET1), during (dPET2, dPET3) and after (dPET4, dPET5) chemoradiation.

IV. To generate preliminary data for future methodology or clinical trials.

OUTLINE:

Patients receive fludeoxyglucose F-18 via injection and undergo dPET over 20 minutes after standard of care computed tomography (CT) imaging (week -2), after receiving 20-26 Gy and 40-46 Gy of radiation (weeks 3 and 5), and 3 months after completion of treatment. Patients with concern for residual disease may receive an additional dPET 6 months after treatment.

Being tested
Fludeoxyglucose F-18, Positron Emission Tomography
Medical subject headings
Oropharyngeal Neoplasms, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fludeoxyglucose F-18Radiation

    Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18

    Given via injection

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo dPET

Study groups in NCT04140513
Study groupRoleWhat they receive
Diagnostic (dPET)ExperimentalPatients receive fludeoxyglucose F-18 via injection and undergo dPET over 20 minutes after standard of care computed tomography (CT) imaging (week -2), after receiving 20-26 Gy and 40-46 Gy of radiation (weeks 3 and 5), and 3 months after completion of treatment. Patients with concern for residual disease may receive an additional dPET 6 months after treatment.
Receives: Radiation: Fludeoxyglucose F-18; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantitative assessments of digital positron emission tomography (dPET) characteristics generated at early time points during treatment

    For each of the promising dPET parameters identified in the primary analysis we will examine potential cut-points to be used to best predict 6-month response/non-response using receiver operating characteristic (ROC) methods. Here we will examine specificity, sensitivity, positive predictive value and negative predictive values for each promising parameter to allow for preliminary data to be generated to anticipate which parameters may warrant future study.

    Measured: Up to 2 years

Secondary outcomes (6)

  1. Tumor burden

    Will compare digital versus conventional PET. Comparison of PET parameters from the dPET or the conventional (c)PET will be visualized using scatterplots; agreement between the two methods will be summarized.

    Measured: Up to 2 years

  2. Response rate for each patient local control

    Will be defined as no evidence of disease at 6 months on physical and endoscopic exam for patient with a compete response on 3 month PET. Will be performed using Kaplan-Meier methods.

    Measured: At 2 years

  3. Progression-free survival (PFS)

    PFS will be performed using Kaplan-Meier methods.

    Measured: Up to 2 years

  4. Standard uptake volume (SUV) from digital/conventional PET

    Will assess SUV and will compare mean values for each interim dPET. The changes of dPET/cPET SUV over the study period will be visualized using longitudinal plot, summarized at each time point, and modeled using linear mixed model for repeated measures.

    Measured: At 3 months

  5. Metabolic tumor volume (MTV) from digital/conventional PET

    Will assess MTV and will compare mean values for each interim dPET. The changes of dPET/cPET MTV over the study period will be visualized using longitudinal plot, summarized at each time point, and modeled using linear mixed model for repeated measures.

    Measured: At 3 months

  6. Total lesion glycolysis (TLG) from digital/conventional PET

    Will calculate TLG based on MTV and SUV and will compare mean values for each interim dPET. The changes of dPET/cPET TLG over the study period will be visualized using longitudinal plot, summarized at each time point, and modeled using linear mixed model for repeated measures.

    Measured: At 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2019
  2. Study start9 Oct 2020
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

Why it stopped: PI decision

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04140513
Sponsor's protocol ID
OSU-19172
Other IDs
NCI-2019-05315
Status last verified
Mar 2024
First submitted
24 Oct 2019
Last updated
8 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Fludeoxyglucose F-18 and Positron Emission Tomography in people with Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by Ohio State University 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 20 inclusion and 14 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 8 Mar 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?

Quantitative assessments of digital positron emission tomography (dPET) characteristics generated at early time points during treatment (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04140513.

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 Mar 2024.

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