Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Mar 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new program called ENDURE to see if it can help patients with head and neck cancer start their follow-up radiation therapy more quickly compared to standard care. The trial aims to answer important questions about whether this program can reduce delays in treatment, especially for patients from different racial backgrounds, and to understand how it helps to speed up the process.

To participate in this trial, candidates must be at least 18 years old and have specific types of head and neck squamous cell carcinoma, which is a type of cancer that can affect areas like the mouth and throat. They should also be planning to undergo surgery at one of the trial sites and need to receive radiation therapy afterward. Participants in the trial will receive support through the ENDURE program while they navigate their treatment, and the study is currently enrolling patients. This is an opportunity for patients to potentially benefit from a more efficient treatment process while contributing to research that could improve care for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \>/= 18 years
• • 2. Squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity
• • 3. American Joint Committee on Cancer (AJCC) 8th edition clinical T3-4 or \>/= N1 SCC of the oral cavity, oropharynx, hypopharynx, larynx, paranasal sinuses, nasal cavity, or unknown primary
• • 4. No history of radiation therapy for treatment of HNSCC in the definitive or adjuvant settings that would, at the discretion of the enrolling clinician, affect the patient's need for adjuvant RT
• • 5. Plan for curative intent surgery at one of the participating centers
• • 6. Plan for PORT (regardless of whether it is at the surgical center) with or without concurrent chemotherapy following curative intent surgery based on the expectation of at least one of the following adverse features on final pathologic evaluation: pT3 or pT4 primary, N1 or greater nodal disease, perineural invasion (PNI), or lymphovascular invasion (LVI).
• Exclusion Criteria:
• • 1. Inability to speak or read English or Spanish.
• • 2. Severe mental illness that would prevent trial participation.
• • 3. HPV-positive OPC or unknown primary SCC staged as cT1-2N1 with a single ipsilateral LN \< 3 cm
• • 4. Synchronous untreated malignancy expected to impact life expectancy