INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy
NCT03953976 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2026-02-19
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
Interventions
- 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
Sponsors & Collaborators
-
University of Texas Southwestern Medical Center
lead OTHER
Principal Investigators
-
David J Sher, MD, MPH · University of Texas Southwestern Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-23
- Primary Completion
- 2022-11-15
- Completion
- 2024-01-22
Countries
- United States
Study Locations
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