Removing the Planning Tumor Volume From Radiation Therapy for the Treatment of Head and Neck Squamous Cell Carcinoma
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Head and Neck Squamous Cell Carcinoma · Hypopharyngeal Squamous Cell Carcinoma · Laryngeal Squamous Cell Carcinoma · Oropharyngeal Squamous Cell Carcinoma · Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8 · Stage I Hypopharyngeal Carcinoma AJCC v8 · Stage I Laryngeal Cancer AJCC v8 · Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8 · Stage II Hypopharyngeal Carcinoma AJCC v8 · Stage II Laryngeal Cancer AJCC v8 · Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8 · Stage III Hypopharyngeal Carcinoma AJCC v8 · Stage III Laryngeal Cancer AJCC v8 · Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 · Stage IVA Hypopharyngeal Carcinoma AJCC v8 · Stage IVA Laryngeal Cancer AJCC v8 · Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8 · Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 30 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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 full description
PRIMARY OBJECTIVES:
I. 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:
I. 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.
V. 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- 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:
- 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)
Exclusion Criteria:
- 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
- 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)
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Treatment (RT without PTV)
Patients 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.
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
Chemotherapy DRUG
Given concurrent chemotherapy
Computed Tomography PROCEDURE
Undergo CT and/or FDG-PET/CT
Endoscopic Procedure PROCEDURE
Undergo laryngopharyngoscopy
FDG-Positron Emission Tomography and Computed Tomography Scan PROCEDURE
Undergo FDG-PET/CT
Image Guided Radiation Therapy RADIATION
Undergo IGRT without PTV
Intensity-Modulated Radiation Therapy RADIATION
Undergo IMRT without PTV
Survey Administration OTHER
Ancillary studies
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Percent of patients experiencing locoregional recurrence and marginal recurrence
Time frame: At 6 months post-radiation therapy
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.
Incidence of treatment-related adverse events
Time frame: From start of treatment to three months post-radiation therapy
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.
Change in Functional Assessment of Cancer Therapy Head and Neck Questionnaire (FACT-H&N) v4.0 scores
Time frame: From baseline to end of treatment and 3 months post-radiation therapy
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.
Change in Eastern Cooperative Oncology Group (ECOG) performance status
Time frame: From baseline to end of treatment and 3 months post-radiation therapy
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.
Secondary measures
Locoregional recurrence rate
Time frame: At 2 and 5 years post-radiation therapy
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.
Local recurrence rates
Time frame: At 3 months, 2 years, and 5 years post-radiation therapy
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.
Regional recurrence rates
Time frame: At 3 months, 2 years, and 5 years post-radiation therapy
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.
Incidence of treatment-related adverse events
Time frame: From start of treatment to 1 year post-radiation therapy
As assessed by CTCAE v6.0, delineated by grade and attribution. Observed toxicities will be summarized by incidence, type, severity, and attribution.
Change in FACT-H&N v4.0 scores
Time frame: From baseline to 6, 9, and 12 months post-radiation therapy
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.
Change in ECOG performance status
Time frame: From baseline to 6, 9, and 12 months post-radiation therapy
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.
Prespecified dosimetric parameters for organs at risk
Time frame: At time of radiation therapy (Up to 6-7 weeks)
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
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1 locations
City of Hope Medical CenterDuarte, California, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- City of Hope Medical Center
- Study start
- Jun 22, 2027 Estimated
- Primary completion
- Dec 22, 2028 Estimated
- Study completion
- Dec 22, 2028 Estimated
- First posted
- Nov 9, 2026 Actual
- Last updated
- Nov 9, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Pilot Study of the Elimination of Planning Tumor Volume (PTV) in Head and Neck Squamous Cell Carcinoma (HNSCC)
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 9, 2026