Spots Global Cancer Trial Database for INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy

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Trial Identification

Brief Title: 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

Study ID: NCT03953976

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

Intensity modulated radiation therapy (IMRT)

Study Description

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.