A Phase 2 interventional study of Intensity modulated radiation therapy (IMRT) in Head and Neck Squamous Cell Carcinoma, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by University of Texas Southwestern Medical Center · Phase 2, Interventional, and Treatment
Elective nodal irradiation has been a longstanding standard-of-care in the management of mucosal squamous cell carcinoma of the head and neck. Recent studies have suggested that reduced elective dose and volume may be a viable approach to improve toxicity. In this study, we are eliminating the elective neck treatment, focusing therapy on involved and suspicious nodes.
We recently completed and reported a successful study (INFIELD) using reduced elective dose (40 Gy) and volume (involved echelons + 1) for oropharynx and larynx cancer. In INRT-AIR (Involved Nodal Radiotherapy using AI-based Radiomics), we are eliminating the elective neck treatment altogether, using radiologic and radiomic-based criteria to focus treatment on the nodes themselves. Eligible patients include previously untreated patients with stage I-IVB oropharynx, larynx and hypopharynx cancer, excluding T1-2 glottic carcinoma. Patients requiring chemotherapy may receive cisplatin, cetuximab, or carboplatin-paclitexel.
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's enrollment of 67 is above the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
7.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Exclusion Criteria:
Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Radiation: Intensity modulated radiation therapy (IMRT)
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy
Risk of Solitary Elective Volume Recurrence Following Elective Volume Reduction Using INRT
Definition: solitary means that the recurrence occurred without a preceding or synchronous in-field or distant recurrence By definition, local recurrence (LR) means disease recurrence in the primary site, and regional recurrence (RR) is a nodal failure anywhere in the neck. Patients who experienced either an LR or RR (or both), were also coded as a locoregional recurrence.
Time frame: 2 years
Comparison of SEVR Risks by Anatomic Site
OS= Overall survival PFS= Progression-free survival
Time frame: 2 years
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales
The EORTC QLQ-C30 is a 30-item instrument (30 questions). Results are calculated from the means of the scores from the summary score and the functional QLQ-C30 scales. Higher scores indicate better quality of life, on a scale from 0 to 100. Patients answer questions that are grouped into the following scales: Summary score (scored from 0-100, with higher scores indicating a better quality of life) -Global (Patients rate overall health and quality of life) Functional scales (each of these is scored from 0-100, with higher scores indicating a better quality of life) * Physical function (ability to perform physical tasks) * Role function (ability to perform daily and work-related activities) * Emotional function (whether patient is experiencing distress, anxiety, depression) * Cognitive function (memory, concentration) * Social function (ability to maintain social activities and relationships)
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom Subscales
Patients report to which extent they experience symptoms or problems during one week. EORTC HN35 subscales are each scored on a scale from 0 to 100, with higher scores indicating worse symptoms. These subscales include dry mouth, sticky saliva, senses (taste/smell), pain, and speech issues
Time frame: Baseline, 3 month, 6 month, 12 month, 24 months
MD Anderson Dysphagia Inventory (MDADI) Global, Emotional, Functional and Physical Subscales
Questionnaire asks for patients' views about swallowing ability. MDADI scores range from 20 to 100, where higher scores represent better swallowing ability.
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months
Skin Toxicity (Dermatitis)
According to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.0 toxicity criteria Higher grades indicate worse adverse events. This is assessed clinically by the patient's physician. Grade 1 is defined as "Faint erythema or dry desquamation" Grade 2 is defined as "Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema" Grade 3 is defined as "Moist Desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion"
Time frame: 2 years
Gastrostomy Placement
Number of patients who experienced gastrostomy dependence for a period of time following treatment with INRT up to 2 years post treatment
Time frame: from end of treatment to 2 years post treatment
EQ-5D Quality of Life Overall Health Visual Analogue Scale (VAS)
Average patient utilities (derived from EQ-5D) at baseline, 1, 3, 6, 12, 18, 24 and 36 months from the end of treatment. The overall health VAS is scored from 0 (worst imaginable health) to 100 (best imaginable health) based on the patient's self-reported health that day.
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months from the end of treatment
2-year Overall and Progression-free Survival Following Treatment With INRT
Overall survival (PFS) is defined as the duration of time from start of treatment to time of progression (LR, RR, or DM) or death. Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression (LR, RR, or DM) or death.
Time frame: 2 years
Time From the End of Treatment for Disease-free Patients to Have Their Gastrostomy Tubes Removed
Median length of gastrostomy dependence following treatment with INRT for patients who had needed a gastrostomy tube inserted and who were deemed disease-free
Time frame: 2 years
| Milestone | INRT |
|---|---|
| Started | 67 |
| Completed | 67 |
| Not completed | 0 |
Definition: solitary means that the recurrence occurred without a preceding or synchronous in-field or distant recurrence By definition, local recurrence (LR) means disease recurrence in the primary site, and regional recurrence (RR) is a nodal failure anywhere in the neck. Patients who experienced either an LR or RR (or both), were also coded as a locoregional recurrence.
| percentage of participants | INRT |
|---|---|
| Locoregional Recurrence | 11 |
| Local Recurrence | 9 |
| Regional Recurrence | 3 |
| Distant Metastasis | 6 |
OS= Overall survival PFS= Progression-free survival
| percentage probability of 2-year OS/PFS | INRT |
|---|---|
| OS Oropharynx | 96 |
| OS Larynx/hypopharynx | 79 |
| PFS Oropharynx | 90 |
| PFS Larynx/hypopharynx | 63 |
The EORTC QLQ-C30 is a 30-item instrument (30 questions). Results are calculated from the means of the scores from the summary score and the functional QLQ-C30 scales. Higher scores indicate better quality of life, on a scale from 0 to 100. Patients answer questions that are grouped into the following scales: Summary score (scored from 0-100, with higher scores indicating a better quality of life) -Global (Patients rate overall health and quality of life) Functional scales (each of these is scored from 0-100, with higher scores indicating a better quality of life) * Physical function (ability to perform physical tasks) * Role function (ability to perform daily and work-related activities) * Emotional function (whether patient is experiencing distress, anxiety, depression) * Cognitive function (memory, concentration) * Social function (ability to maintain social activities and relationships)
| score on a scale | INRT |
|---|---|
| Global Baseline | 76.9 ± 2.5 |
| Global 3M | 80.7 ± 2.4 |
| Global 6M | 85.6 ± 2.2 |
| Global 12M | 84.5 ± 2.2 |
| Global 24M | 87.5 ± 2.1 |
| Physical fcn baseline | 92.7 ± 1.7 |
| Physical fcn 3M | 89.9 ± 1.9 |
| Physical fcn 6M | 94.2 ± 1.8 |
| Physical fcn 12M | 94.5 ± 1.6 |
| Physical fcn 24M | 96.9 ± 1.3 |
| Role fcn baseline | 91.4 ± 2.1 |
| Role fcn 3M | 86.7 ± 2.9 |
| Role fcn 6M | 94.6 ± 2.1 |
| Role fcn 12M | 94.4 ± 2.1 |
| Role fcn 24M | 97.5 ± 1.3 |
| Emotional fcn baseline | 84.6 ± 2.1 |
| Emotional fcn 3M | 88.2 ± 2.4 |
| Emotional fcn 6M | 88.6 ± 2.5 |
| Emotional fcn 12M | 88.3 ± 2.1 |
| Emotional fcn 24M | 92.3 ± 1.7 |
| Cognitive fcn baseline | 92.0 ± 1.5 |
| Cognitive fcn 3M | 88.6 ± 2.3 |
| Cognitive fcn 6M | 88.5 ± 2.4 |
| Cognitive fcn 12M | 86.9 ± 2.3 |
| Cognitive fcn 24M | 92.9 ± 1.7 |
| Social fcn baseline | 89.1 ± 2.2 |
| Social fcn 3M | 88.6 ± 2.7 |
| Social fcn 6M | 93.0 ± 1.9 |
| Social fcn 12M | 93.0 ± 1.9 |
| Social fcn 24M | 97.1 ± 1.3 |
Patients report to which extent they experience symptoms or problems during one week. EORTC HN35 subscales are each scored on a scale from 0 to 100, with higher scores indicating worse symptoms. These subscales include dry mouth, sticky saliva, senses (taste/smell), pain, and speech issues
| score on a scale | INRT |
|---|---|
| HN35 Dry Mouth Baseline | 13.4 ± 3.0 |
| HN35 Dry Mouth 3M | 49.7 ± 4.0 |
| HN35 Dry Mouth 6M | 36.5 ± 3.4 |
| HN35 Dry Mouth 12M | 32.7 ± 3.2 |
| HN35 Dry Mouth 24M | 24.4 ± 3.9 |
| HN35 Sticky Saliva Baseline | 11.4 ± 3.0 |
| HN35 Sticky Saliva 3M | 35.8 ± 4.1 |
| HN35 Sticky Saliva 6M | 22.6 ± 3.3 |
| HN35 Sticky Saliva 12M | 20.0 ± 3.2 |
| HN35 Sticky Saliva 24M | 13.8 ± 2.8 |
| HN35 Senses Baseline | 6.2 ± 1.8 |
| HN35 Senses 3M | 21.9 ± 3.0 |
| HN35 Senses 6M | 14.8 ± 2.4 |
| HN35 Senses 12M | 13.7 ± 2.4 |
| HN35 Senses 24M | 9.3 ± 2.1 |
| HN35 Pain Baseline | 20.9 ± 3.2 |
| HN35 Pain 3M | 14.4 ± 2.8 |
| HN35 Pain 6M | 10.1 ± 1.5 |
| HN35 Pain 12M | 6.1 ± 1.3 |
| HN35 Pain 24M | 6.1 ± 1.4 |
| HN35 Speech Baseline | 15.0 ± 2.7 |
| HN35 Speech 3M | 10.7 ± 2.3 |
| HN35 Speech 6M | 6.1 ± 1.6 |
| HN35 Speech 12M | 6.5 ± 1.7 |
| HN35 Speech 24M | 4.3 ± 1.6 |
Questionnaire asks for patients' views about swallowing ability. MDADI scores range from 20 to 100, where higher scores represent better swallowing ability.
| score on a scale | INRT |
|---|---|
| Composite MDADI Baseline | 83.1 ± 1.9 |
| Composite MDADI 3M | 83.8 ± 2.6 |
| Composite MDADI 6M | 90.6 ± 1.4 |
| Composite MDADI 12M | 89.1 ± 1.6 |
| Composite MDADI 24M | 92.6 ± 1.3 |
According to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.0 toxicity criteria Higher grades indicate worse adverse events. This is assessed clinically by the patient's physician. Grade 1 is defined as "Faint erythema or dry desquamation" Grade 2 is defined as "Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema" Grade 3 is defined as "Moist Desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion"
| percentage of patients with toxicity | INRT |
|---|---|
| Grade 1 dermatitis | 90 |
| Grade 2 dermatitis | 10 |
| Grade 3 dermatitis | 0 |
Number of patients who experienced gastrostomy dependence for a period of time following treatment with INRT up to 2 years post treatment
| Participants | INRT |
|---|---|
| Gastrostomy Placement | 14 |
Average patient utilities (derived from EQ-5D) at baseline, 1, 3, 6, 12, 18, 24 and 36 months from the end of treatment. The overall health VAS is scored from 0 (worst imaginable health) to 100 (best imaginable health) based on the patient's self-reported health that day.
| score on a scale | INRT |
|---|---|
| Baseline | 75.97 (3 to 100) |
| 1M | 75.15 (6 to 100) |
| 3M | 78.75 (6 to 100) |
| 6M | 84.07 (7 to 100) |
| 12M | 83.83 (8 to 100) |
| 18M | 89.87 (72 to 100) |
| 24M | 87.0 (33 to 100) |
| 36M | 89.05 (65 to 100) |
Overall survival (PFS) is defined as the duration of time from start of treatment to time of progression (LR, RR, or DM) or death. Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression (LR, RR, or DM) or death.
| percentage probability of 2-year OS/PFS | INRT |
|---|---|
| Overall survival | 91 |
| Progression-free survival | 82 |
Median length of gastrostomy dependence following treatment with INRT for patients who had needed a gastrostomy tube inserted and who were deemed disease-free
| months from end of treatment | INRT |
|---|---|
| Time From the End of Treatment for Disease-free Patients to Have Their Gastrostomy Tubes Removed | 2.9 (2.6 to 4.4) |
Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| INRT | 1/67 (1.5%) | 12/67 (17.9%) | 67/67 (100%) |
| Event | INRT |
|---|---|
| DysphagiaGastrointestinal disorders | 3/67 |
| PneumoniaInfections and infestations | 2/67 |
| DehydrationMetabolism and nutrition disorders | 2/67 |
| HypotensionVascular disorders | 2/67 |
| Abdominal PainGastrointestinal disorders | 1/67 |
| Pulmonary EdemaRespiratory, thoracic and mediastinal disorders | 1/67 |
| Acute Kidney InjuryRenal and urinary disorders | 1/67 |
| Altered Mental StatusPsychiatric disorders | 1/67 |
| AnorexiaMetabolism and nutrition disorders | 1/67 |
| AspirationRespiratory, thoracic and mediastinal disorders | 1/67 |
| Event | INRT |
|---|---|
| Dry mouthGastrointestinal disorders | 56/67 |
| Dermatitis radiationInjury, poisoning and procedural complications | 52/67 |
| DysgeusiaNervous system disorders | 47/67 |
| NauseaGastrointestinal disorders | 47/67 |
| DysphagiaGastrointestinal disorders | 45/67 |
| FatigueGeneral disorders | 43/67 |
| Mucositis oralGastrointestinal disorders | 43/67 |
| HypertensionVascular disorders | 42/67 |
| Sore throatGastrointestinal disorders | 39/67 |
| ConstipationGastrointestinal disorders | 37/67 |
| Age, Continuous(years) | INRT |
|---|---|
| Median | 62 (55 to 70) |
| Sex: Female, Male(Participants) | INRT |
|---|---|
| Female | 14 |
| Male | 53 |
| Ethnicity (NIH/OMB)(Participants) | INRT |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 66 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | INRT |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 61 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Disease Site(Participants) | INRT |
|---|---|
| p16+ Oropharynx | 43 |
| p16- oropharynx | 5 |
| Larynx/hypopharynx | 19 |
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Squamous Cell Carcinoma of Head and Neck→
University of Texas Southwestern Medical Center