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

Recruiting now · Not applicable

Conditions studied: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer, Oral Cavity Cancer, Larynx Cancer

In brief

The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual (TAU) to improve the initiation of guideline-adherent postoperative radiation therapy among patients with head and neck cancer. The main questions the trial aims to answer are: 1. Does ENDURE improve initiation of timely PORT relative to treatment as usual? 2. What are the mechanisms through which ENDURE improves timeliness to treatment? 3. What are the barriers and facilitators to the implementation of ENDURE into routine clinical care?

Key facts

Study ID

NCT05793151

Run by

Medical University of South Carolina

People needed

532

Starts

2023-10-30

Expected to finish

2028-03-30

Last updated by the study team

2025-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >/= 18 years
• Squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity
• 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.
• 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.
• Plan for curative intent surgery at one of the participating centers
• 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).

You may not qualify if…

• Inability to speak or read English or Spanish.
• Severe mental illness that would prevent trial participation.
• HPV-positive OPC or unknown primary SCC staged as cT1-2N1 with a single ipsilateral LN < 3 cm
• Synchronous untreated malignancy expected to impact life expectancy

Where it is running

• Washington University in St. Louis — St Louis, Missouri, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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