INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy
CompletedPhase 2Results postedLast updated 19 February 2026
What this trial tests
Phase 2 trial testing Intensity modulated radiation therapy (IMRT) in Head and Neck Squamous Cell Carcinoma in 67 participants. Completed in 22 January 2024.
18 and older, any sex, with Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Risk of Solitary Elective Volume Recurrence Following Elective Volume Reduction Using INRTPrimary· 2 years
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.
Locoregional Recurrence
Group
Value
95% CI
INRT
11
Local Recurrence
Group
Value
95% CI
INRT
9
Regional Recurrence
Group
Value
95% CI
INRT
3
Distant Metastasis
Group
Value
95% CI
INRT
6
Comparison of SEVR Risks by Anatomic SiteSecondary· 2 years
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional SubscalesSecondary· Baseline, 3 months, 6 months, 12 months, 24 months
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 (abi
Global Baseline
Group
Value
95% CI
INRT
76.9
± 2.5
Global 3M
Group
Value
95% CI
INRT
80.7
± 2.4
Global 6M
Group
Value
95% CI
INRT
85.6
± 2.2
Global 12M
Group
Value
95% CI
INRT
84.5
± 2.2
Global 24M
Group
Value
95% CI
INRT
87.5
± 2.1
Physical fcn baseline
Group
Value
95% CI
INRT
92.7
± 1.7
Physical fcn 3M
Group
Value
95% CI
INRT
89.9
± 1.9
Physical fcn 6M
Group
Value
95% CI
INRT
94.2
± 1.8
European Organization for Research and Treatment of Cancer Head and Neck 35-question Questionnaire (EORTC HN35) Symptom SubscalesSecondary· Baseline, 3 month, 6 month, 12 month, 24 months
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
HN35 Dry Mouth Baseline
Group
Value
95% CI
INRT
13.4
± 3.0
HN35 Dry Mouth 3M
Group
Value
95% CI
INRT
49.7
± 4.0
HN35 Dry Mouth 6M
Group
Value
95% CI
INRT
36.5
± 3.4
HN35 Dry Mouth 12M
Group
Value
95% CI
INRT
32.7
± 3.2
HN35 Dry Mouth 24M
Group
Value
95% CI
INRT
24.4
± 3.9
HN35 Sticky Saliva Baseline
Group
Value
95% CI
INRT
11.4
± 3.0
HN35 Sticky Saliva 3M
Group
Value
95% CI
INRT
35.8
± 4.1
HN35 Sticky Saliva 6M
Group
Value
95% CI
INRT
22.6
± 3.3
MD Anderson Dysphagia Inventory (MDADI) Global, Emotional, Functional and Physical SubscalesSecondary· Baseline, 3 months, 6 months, 12 months, 24 months
Questionnaire asks for patients' views about swallowing ability. MDADI scores range from 20 to 100, where higher scores represent better swallowing ability.
Composite MDADI Baseline
Group
Value
95% CI
INRT
83.1
± 1.9
Composite MDADI 3M
Group
Value
95% CI
INRT
83.8
± 2.6
Composite MDADI 6M
Group
Value
95% CI
INRT
90.6
± 1.4
Composite MDADI 12M
Group
Value
95% CI
INRT
89.1
± 1.6
Composite MDADI 24M
Group
Value
95% CI
INRT
92.6
± 1.3
Skin Toxicity (Dermatitis)Secondary· 2 years
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"
Grade 1 dermatitis
Group
Value
95% CI
INRT
90
Grade 2 dermatitis
Group
Value
95% CI
INRT
10
Grade 3 dermatitis
Group
Value
95% CI
INRT
0
Gastrostomy PlacementSecondary· from end of treatment to 2 years post treatment
Number of patients who experienced gastrostomy dependence for a period of time following treatment with INRT up to 2 years post treatment
Group
Value
95% CI
INRT
14
EQ-5D Quality of Life Overall Health Visual Analogue Scale (VAS)Secondary· Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months from the end of treatment
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.
Baseline
Group
Value
95% CI
INRT
75.97
3 – 100
1M
Group
Value
95% CI
INRT
75.15
6 – 100
3M
Group
Value
95% CI
INRT
78.75
6 – 100
6M
Group
Value
95% CI
INRT
84.07
7 – 100
12M
Group
Value
95% CI
INRT
83.83
8 – 100
18M
Group
Value
95% CI
INRT
89.87
72 – 100
24M
Group
Value
95% CI
INRT
87.0
33 – 100
36M
Group
Value
95% CI
INRT
89.05
65 – 100
2-year Overall and Progression-free Survival Following Treatment With INRTSecondary· 2 years
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.
Overall survival
Group
Value
95% CI
INRT
91
Progression-free survival
Group
Value
95% CI
INRT
82
Time From the End of Treatment for Disease-free Patients to Have Their Gastrostomy Tubes RemovedSecondary· 2 years
Median length of gastrostomy dependence following treatment with INRT for patients who had needed a gastrostomy tube inserted and who were deemed disease-free
Group
Value
95% CI
INRT
2.9
2.6 – 4.4
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 19 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03953976.