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Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8NCT07926906

Removing the Planning Tumor Volume From Radiation Therapy for the Treatment of Head and Neck Squamous Cell Carcinoma

A study testing Chemotherapy, Computed Tomography and Endoscopic Procedure in people with Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by City of Hope Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This clinical trial studies the side effects and how well removing the planning tumor volume (PTV) from radiation therapy (RT) works in treating patients with head and neck squamous cell carcinoma (HNSCC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Chemotherapy, Computed Tomography and Endoscopic Procedure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
22 Jun 2027to 22 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Documented informed consent of the participant and/or Legally Authorized Representative
  • Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines
  • Age: ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2
  • Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma but not neuroendocrine phenotype) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls), larynx and hypopharynx; cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage)
  • No metastatic disease and eligible for definitive radiation based on the following diagnostic workup:
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  • General history and physical examination within 56 days prior to registration
  • Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable) within 70 days prior to registration
  • FDG -PET/CT (with or without contrast) within 60 days prior to registration
  • Diagnostic CT scan of neck (with contrast and of diagnostic quality) within 60 days prior to registration
  • Planning to undergo definitive radiation (with or without chemotherapy)
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

Who cannot join

  • Recurrent disease
  • T1-T2 glottic cancers
  • Definitive clinical or radiologic evidence of metastatic diseases
  • Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, even if p16-positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas
  • Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed. Patients with unknown primary or resected primary are eligible if gross nodal disease is present
  • Patients with simultaneous primary cancers or separate bilateral primary tumor sites are excluded with the exception of patients with bilateral tonsil cancers
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  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days or five half-lives (whichever is shorter for non-radiation therapy) prior to day 1 of protocol therapy
  • Severe, active co-morbidity defined as follows:
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition with immune compromise. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible. HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Hepatitis B testing is not required for entry into this protocol
  • Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment for the hepatitis, they are eligible if they have an undetectable HCV viral load. Hepatitis C testing is not required for entry into this protocol
  • Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy
  • Clinically significant uncontrolled illness
  • Females only: Pregnant or breastfeeding
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

    Arya Amini, 626-218-2247, aamini@coh.org

    Arya Amini

Other trials in United States

About this study

Official title: Pilot Study of the Elimination of Planning Tumor Volume (PTV) in Head and Neck Squamous Cell Carcinoma (HNSCC)

This clinical trial studies the side effects and how well removing the planning tumor volume (PTV) from radiation therapy (RT) works in treating patients with head and neck squamous cell carcinoma (HNSCC). Standard therapy for HNSCC often involves giving RT with chemotherapy; however, this approach is associated with a high level of short- and long-term side effects. RT uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. RT is planned to be delivered based on three volumes of the tumor. The first is the gross tumor volume which is the area of the tumor that can be seen, felt, or measured on imaging. The second is the clinical tumor volume which includes the gross tumor volume as well as area beyond this to account for disease that cannot be seen on imaging and may have spread. The third is the PTV which includes an area beyond both the gross tumor volume and clinical tumor volume to account for errors that may happen during RT, such as setup error or movement. As the area between the clinical tumor volume and PTV is not cancer and current advances in RT have improved RT accuracy, researchers think that removing PTV from RT may lower side effects while still being an effective treatment. Removing the PTV from RT may safe, tolerable, and/or effective in treating patients with HNSCC.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Describe the effect of eliminating PTV on locoregional control and marginal recurrence at 6 months in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

II. Describe the effect of PTV on early toxicity, PRO (patient reported outcomes) and QOL (quality of life) in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

SECONDARY OBJECTIVES:

  1. Describe the effect of eliminating PTV on locoregional control at 2 and 5 years in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

II. Describe the patterns of failure when eliminating PTV at 3 months, 2 years and 5 years in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

III. Describe the effect of eliminating PTV on later toxicity in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

IV. Describe the effect of eliminating PTV on later PRO (patient reported outcomes) and QOL (quality of life) in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

  1. Describe differences in dosimetric comparison plans with and without PTV in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

VI. Describe the effect of eliminating PTV on marginal recurrence rate at 2 and 5 years in patients with HNSCC undergoing definitive RT, with or without chemotherapy.

OUTLINE:

Patients undergo intensity-modulated radiation therapy (IMRT) or image-guided radiation therapy (IGRT) without PTV 5-6 times a week for thirty-five treatment fractions over 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive concurrent chemotherapy on study. Additionally, patients undergo computed tomography (CT), fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT, and laryngopharyngoscopy during screening and CT or FDG-PET/CT during follow up.

After completion of study treatment, patients are followed up every 3 months during years 1-2 and then every 6 months during years 3-5.

Being tested
Chemotherapy, Computed Tomography, Endoscopic Procedure, FDG-Positron Emission Tomography and Computed Tomography Scan, Image Guided Radiation Therapy
Medical subject headings
Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Hypopharyngeal Neoplasms, Laryngeal Neoplasms

What participants receive

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

  • ChemotherapyDrug

    Also called Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General

    Given concurrent chemotherapy

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT and/or FDG-PET/CT

  • Endoscopic ProcedureProcedure or surgery

    Also called Endoscopic Examination, Endoscopy, ES

    Undergo laryngopharyngoscopy

  • FDG-Positron Emission Tomography and Computed Tomography ScanProcedure or surgery

    Also called FDG PET/CT

    Undergo FDG-PET/CT

  • Image Guided Radiation TherapyRadiation

    Also called IGRT, Image Guided Radiotherapy, image-guided radiation therapy, Image-Guided Radiotherapy

    Undergo IGRT without PTV

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo IMRT without PTV

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT07926906
Study groupRoleWhat they receive
Treatment (RT without PTV)ExperimentalPatients undergo IMRT or IGRT without PTV 5-6 times a week for thirty-five treatment fractions over 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive concurrent chemotherapy on study. Additionally, patients undergo CT, FDG-PET/CT, and laryngopharyngoscopy during screening and CT or FDG-PET/CT during follow up.
Receives: Drug: Chemotherapy; Procedure: Computed Tomography; Procedure: Endoscopic Procedure; Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan; Radiation: Image Guided Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Other: Survey Administration

What is being measured

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

  1. Percent of patients experiencing locoregional recurrence and marginal recurrence

    Will be summarized using descriptive statistics. Will be calculated using the number of patients local or regional recurrence and marginal recurrence divided by the total number of treated/evaluable subjects. Point estimates and two-sided 95% exact binomial confidence intervals will be reported. As secondary analyses, time to locoregional recurrence will be measured from completion of radiation therapy to the first documented local or regional recurrence. The cumulative incidence of locoregional recurrence at 3 months, 2 years, and 5 years will be estimated. Patients alive and free of locoregional recurrence will be censored at the date of their last contact. Point estimates and two-sided 95% confidence intervals will be reported.

    Measured: At 6 months post-radiation therapy

  2. Incidence of treatment-related adverse events

    As assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0, delineated by grade and attribution. Observed toxicities will be summarized by incidence, type, severity, and attribution.

    Measured: From start of treatment to three months post-radiation therapy

  3. Change in Functional Assessment of Cancer Therapy Head and Neck Questionnaire (FACT-H&N) v4.0 scores

    At each post-baseline time point, the observed score and change from baseline will be summarized using descriptive statistics, together with the mean change and its two-sided 95% confidence interval. The number of patients with available assessments will be reported at each time point. (Generalized) linear mixed-effects models may be used to characterize changes over time for exploratory analyses.

    Measured: From baseline to end of treatment and 3 months post-radiation therapy

  4. Change in Eastern Cooperative Oncology Group (ECOG) performance status

    At each post-baseline time point, the observed score and change from baseline will be summarized using descriptive statistics, together with the mean change and its two-sided 95% confidence interval. The number of patients with available assessments will be reported at each time point. (Generalized) linear mixed-effects models may be used to characterize changes over time for exploratory analyses.

    Measured: From baseline to end of treatment and 3 months post-radiation therapy

Secondary outcomes (7)

  1. Locoregional recurrence rate

    Will be summarized using descriptive statistics. Will be calculated using the number of patients local or regional recurrence and marginal recurrence divided by the total number of treated/evaluable subjects. Point estimates and two-sided 95% exact binomial confidence intervals will be reported. As secondary analyses, time to locoregional recurrence will be measured from completion of radiation therapy to the first documented local or regional recurrence. The cumulative incidence of locoregional recurrence at 3 months, 2 years, and 5 years will be estimated. Patients alive and free of locoregional recurrence will be censored at the date of their last contact. Point estimates and two-sided 95% confidence intervals will be reported.

    Measured: At 2 and 5 years post-radiation therapy

  2. Local recurrence rates

    Will be summarized using descriptive statistics. Will be calculated using the number of patients local recurrence divided by the total number of treated/evaluable subjects. Point estimates and two-sided 95% exact binomial confidence intervals will be reported. As secondary analyses, time to local recurrence will be measured from completion of radiation therapy to the first documented local recurrence. The cumulative incidence of local recurrence at 3 months, 2 years, and 5 years will be estimated. Patients alive and free of local recurrence will be censored at the date of their last contact. Point estimates and two-sided 95% confidence intervals will be reported.

    Measured: At 3 months, 2 years, and 5 years post-radiation therapy

  3. Regional recurrence rates

    Will be summarized using descriptive statistics. Will be calculated using the number of patients regional recurrence divided by the total number of treated/evaluable subjects. Point estimates and two-sided 95% exact binomial confidence intervals will be reported. As secondary analyses, time to regional recurrence will be measured from completion of radiation therapy to the first documented regional recurrence. The cumulative incidence of regional recurrence at 3 months, 2 years, and 5 years will be estimated. Patients alive and free of regional recurrence will be censored at the date of their last contact. Point estimates and two-sided 95% confidence intervals will be reported.

    Measured: At 3 months, 2 years, and 5 years post-radiation therapy

  4. Incidence of treatment-related adverse events

    As assessed by CTCAE v6.0, delineated by grade and attribution. Observed toxicities will be summarized by incidence, type, severity, and attribution.

    Measured: From start of treatment to 1 year post-radiation therapy

  5. Change in FACT-H&N v4.0 scores

    At each post-baseline time point, the observed score and change from baseline will be summarized using descriptive statistics, together with the mean change and its two-sided 95% confidence interval. The number of patients with available assessments will be reported at each time point. (Generalized) linear mixed-effects models may be used to characterize changes over time for exploratory analyses.

    Measured: From baseline to 6, 9, and 12 months post-radiation therapy

  6. Change in ECOG performance status

    At each post-baseline time point, the observed score and change from baseline will be summarized using descriptive statistics, together with the mean change and its two-sided 95% confidence interval. The number of patients with available assessments will be reported at each time point. (Generalized) linear mixed-effects models may be used to characterize changes over time for exploratory analyses.

    Measured: From baseline to 6, 9, and 12 months post-radiation therapy

  7. Prespecified dosimetric parameters for organs at risk

    Will be summarized separately for the delivered plan without planning tumor volume (PTV) and the comparison plan generated using PTV. Because both plans are generated for the same patient, the dosimetric quantity will be the within-patient difference between plans. Any formal paired comparisons will be considered exploratory.

    Measured: At time of radiation therapy (Up to 6-7 weeks)

Timeline

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

  1. First posted9 Nov 2026
  2. Study start22 Jun 2027 (estimated)
  3. Primary completion22 Dec 2028 (estimated)
  4. Study completion22 Dec 2028 (estimated)

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07926906
Sponsor's protocol ID
25155
Other IDs
NCI-2026-07861, 25155, P30CA033572
Status last verified
Nov 2026
First submitted
3 Nov 2026
Last updated
9 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Chemotherapy, Computed Tomography and Endoscopic Procedure in people with Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by City of Hope Medical 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 14 inclusion and 21 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: opening soon, as of the sponsor's last update on 9 Nov 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of patients experiencing locoregional recurrence and marginal recurrence (time frame: At 6 months post-radiation therapy). The study lists 4 primary outcomes in all. 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 NCT07926906.

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 9 Nov 2026.

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