Removing the Planning Tumor Volume From Radiation Therapy for the Treatment of Head and Neck Squamous Cell Carcinoma
NCT07926906, Not applicable, Not yet recruiting, City of Hope Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Removing the Planning Tumor Volume From Radiation Therapy for the Treatment of Head and Neck Squamous Cell Carcinoma | ClinicalTrials.gov |
| NCT number | NCT07926906 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | City of Hope Medical Center | ClinicalTrials.gov |
| Conditions | 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 | ClinicalTrials.gov |
| Interventions | Chemotherapy, Computed Tomography, Endoscopic Procedure, FDG-Positron Emission Tomography and Computed Tomography Scan, Image Guided Radiation Therapy, Intensity-Modulated Radiation Therapy, Survey Administration | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Percent of patients experiencing locoregional recurrence and marginal recurrence | 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. | ClinicalTrials.gov |
| Primary | Incidence of treatment-related adverse events | 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. | ClinicalTrials.gov |
| Primary | Change in Functional Assessment of Cancer Therapy Head and Neck Questionnaire (FACT-H&N) v4.0 scores | 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. | ClinicalTrials.gov |
| Primary | Change in Eastern Cooperative Oncology Group (ECOG) performance status | 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. | ClinicalTrials.gov |
| Secondary | Locoregional recurrence rate | 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. | ClinicalTrials.gov |
| Secondary | Local recurrence rates | 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. | ClinicalTrials.gov |
| Secondary | Regional recurrence rates | 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. | ClinicalTrials.gov |
| Secondary | Incidence of treatment-related adverse events | 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. | ClinicalTrials.gov |
| Secondary | Change in FACT-H&N v4.0 scores | 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. | ClinicalTrials.gov |
| Secondary | Change in ECOG performance status | 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. | ClinicalTrials.gov |
| Secondary | Prespecified dosimetric parameters for organs at risk | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)