Comparing navigation support to standard care for starting radiation therapy in head and neck cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a navigation-based intervention called ENDURE compared to standard treatment in facilitating timely initiation of postoperative radiation therapy (PORT) for patients with head and neck cancer. The study will involve four cancer centers and approximately 484 patients, utilizing a stepped-wedge cluster randomized design to assess the impact of ENDURE on treatment initiation and address racial disparities. Additionally, the trial will explore the mechanisms by which ENDURE may improve treatment timeliness through mixed-methods research, including both quantitative and qualitative data collection.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Evan M Graboyes, MD, MPH — Medical University of South Carolina
• Study coordinator: Evan M Graboyes, MD, MPH
• Email: graboyes@musc.edu
• Phone: 843-792-0719

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.