---
title: "INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy"
nct_id: NCT03953976
overall_status: COMPLETED
phase: PHASE2
sponsor: University of Texas Southwestern Medical Center
study_type: INTERVENTIONAL
primary_condition: Head and Neck Squamous Cell Carcinoma
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03953976.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03953976"
ct_last_update_post_date: 2026-02-19
last_seen_at: "2026-05-12T06:01:42.394Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy

**Official Title:** INRT- AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy Using Artificial Intelligence-Based Radiomics for Head and Neck Squamous Cell Carcinoma

**NCT ID:** [NCT03953976](https://clinicaltrials.gov/study/NCT03953976)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 67
- **Lead Sponsor:** University of Texas Southwestern Medical Center
- **Conditions:** Head and Neck Squamous Cell Carcinoma
- **Start Date:** 2019-07-23
- **Completion Date:** 2024-01-22
- **CT.gov Last Update:** 2026-02-19

## Brief Summary

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.

## Detailed Description

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
2. Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Diagnostic lymph node excision (\< 2 nodes) is also allowable.
3. Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.
4. Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
5. Age ≥ 18 years.
6. ECOG Performance Status 0-2
7. 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:
   * Has not undergone a hysterectomy or bilateral oophorectomy; or
   * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
8. Negative serum pregnancy test within 2 weeks before registration for women of childbearing potential.
9. Neck CT and/or neck MRI, and PET-CT (at least skull-to-thigh).
10. Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

1. Distant metastasis.
2. Inability to undergo PET-CT.
3. Stage I and II glottic carcinoma.
4. Gross total excision of both the primary and nodal disease.
5. Synchronous non-skin cancer primaries outside of the oropharynx, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer; in the latter case, surgery may occur before or after treatment, provided all other eligibility criteria are met .
6. Prior invasive malignancy with an expected disease-free interval of less than 3 years.
7. Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable
8. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
9. Subjects may not be receiving any other investigational agents.
10. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary).
11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
12. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
13. History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.
```

## Arms

- **PET-CT at 3 months and ENT evaluation** (EXPERIMENTAL) — 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

## Interventions

- **Intensity modulated radiation therapy (IMRT)** (RADIATION) — 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

## Primary Outcomes

- **Risk of Solitary Elective Volume Recurrence Following Elective Volume Reduction Using INRT** _(time frame: 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.

## Secondary Outcomes

- **Comparison of SEVR Risks by Anatomic Site** _(time frame: 2 years)_
- **European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales** _(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** _(time frame: Baseline, 3 month, 6 month, 12 month, 24 months)_
- **MD Anderson Dysphagia Inventory (MDADI) Global, Emotional, Functional and Physical Subscales** _(time frame: Baseline, 3 months, 6 months, 12 months, 24 months)_
- **Skin Toxicity (Dermatitis)** _(time frame: 2 years)_
- **Gastrostomy Placement** _(time frame: from end of treatment to 2 years post treatment)_
- **EQ-5D Quality of Life Overall Health Visual Analogue Scale (VAS)** _(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** _(time frame: 2 years)_
- **Time From the End of Treatment for Disease-free Patients to Have Their Gastrostomy Tubes Removed** _(time frame: 2 years)_

## Locations (1)

- University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of texas southwestern medical center - dallas|dallas|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03953976.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03953976*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*