Trial results for a study investigating Involved Nodal Radiation Therapy (INRT) in Head and Neck Cancer were posted on ClinicalTrials.gov on 2026-02-19, with 67 participants enrolled.
Background
Head and Neck Squamous Cell Carcinoma (HNSCC) often involves elective nodal irradiation as a standard-of-care treatment. This approach aims to target potential microscopic disease in lymph nodes that are not clinically involved. However, reducing the elective dose and volume of radiation has been explored as a strategy to potentially decrease treatment-related toxicity. The INRT-AIR study aimed to investigate an approach that eliminates elective neck treatment, focusing radiation therapy specifically on involved and suspicious nodes.
Trial design
The INRT-AIR study (NCT03953976) was a completed Phase II prospective study that enrolled 67 participants. The trial focused on patients with Head and Neck Squamous Cell Carcinoma. The intervention involved Involved Nodal Radiation Therapy (INRT), which aimed to eliminate elective neck treatment and focus therapy on involved and suspicious nodes. The study sought to evaluate outcomes related to this reduced elective volume approach.
Key results
The trial reported several key measurements for participants receiving Involved Nodal Radiation Therapy (INRT):
- Risk of Solitary Elective Volume Recurrence Following Elective Volume Reduction Using INRT (percentage of participants):
- 11
- 9
- 3
- 6
- Comparison of SEVR Risks by Anatomic Site (percentage probability of 2-year OS/PFS):
- 96
- 79
- 90
- 63
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Summary Score and Functional Subscales (score on a scale):
- A mean score of 76.9 (Standard Error 2.5) was observed.
- A mean score of 80.7 (Standard Error 2.4) was observed.
- A mean score of 85.6 (Standard Error 2.2) was observed.
- A mean score of 84.5 (Standard Error 2.2) was observed.
What this means
The results from this Phase II study provide specific data points regarding the efficacy and patient experience with Involved Nodal Radiation Therapy (INRT) for Head and Neck Squamous Cell Carcinoma. The reported percentages for solitary elective volume recurrence and 2-year overall survival/progression-free survival probabilities offer insights into the oncological outcomes of this reduced elective volume approach. Furthermore, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores contribute to understanding the patient-reported quality of life under this treatment strategy. These findings can help inform further research and potential refinements in radiation therapy protocols for head and neck cancer, particularly concerning the balance between disease control and treatment-related toxicity.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03953976, titled "INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy", were posted on 2026-02-19 on clinicaltrials.gov.