INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy

NCT03953976 | Completed Phase 2 Results DMC

• 1 other identifier: STU 2019-0711
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (9)

• Comparison of SEVR Risks by Anatomic Site

  2 years

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales

  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

  Baseline, 3 month, 6 month, 12 month, 24 months

• MD Anderson Dysphagia Inventory (MDADI) Global, Emotional, Functional and Physical Subscales

  Baseline, 3 months, 6 months, 12 months, 24 months

• Skin Toxicity (Dermatitis)

  2 years

Study Arms (1)

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

Radiation: Intensity modulated radiation therapy (IMRT)

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

PET-CT at 3 months and ENT evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
• 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.
• Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.
• Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
• Age ≥ 18 years.
• ECOG Performance Status 0-2
• 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.
• 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).
• Negative serum pregnancy test within 2 weeks before registration for women of childbearing potential.
• Neck CT and/or neck MRI, and PET-CT (at least skull-to-thigh).
• Ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

• Distant metastasis.
• Inability to undergo PET-CT.
• Stage I and II glottic carcinoma.
• Gross total excision of both the primary and nodal disease.
• 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 .
• Prior invasive malignancy with an expected disease-free interval of less than 3 years.
• Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
• Subjects may not be receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary).
• 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
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
• History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: David Sher, MD
• Organization: University of Texas Southwestern Medical Center

david.sher@utsouthwestern.edu

(214)645-7607

Study Officials

• David J Sher, MD, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 17, 2019
• Study Start: July 23, 2019
• Primary Completion: November 15, 2022
• Study Completion: January 22, 2024
• Last Updated: February 19, 2026
• Results First Posted: February 19, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)