Head and Neck Cancer Clinical Trial
— ENDUREOfficial title:
A Stepped Wedge Cluster Randomized Trial Comparing a Navigation-Based Multilevel Intervention With Treatment as Usual to Decrease Delays Starting Postoperative Radiation Therapy in Adults With Head and Neck Cancer
The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual at decreasing delays starting guideline-adherent postoperative radiation therapy among patients with head and neck cancer. The main questions the trial aims to answer are: - Does ENDURE decrease delays starting PORT relative to treatment as usual? - Does ENDURE decrease racial disparities in delays starting PORT relative to treatment as usual - What are the mechanisms through which ENDURE reduces treatment delays?
Status | Recruiting |
Enrollment | 532 |
Est. completion date | March 30, 2028 |
Est. primary completion date | March 30, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) clinical stage grouping III-IV (8th edition) for patients with SCC of the oral cavity, p16-negative oropharynx, hypopharynx, larynx, paranasal sinuses, and nasal cavity or AJCC clinical stage grouping III-IV (7th edition) for patients with p16-positive SCC of the oropharynx or unknown primary. 4. No history of radiation therapy for treatment of HNSCC in the definitive or adjuvant settings.Plan to undergo surgery at a participating site 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 write English 2. Severe mental illness that would prevent trial participation 3. Synchronous untreated malignancy expected to impact life expectancy |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Michael E DeBakey Veterans Affairs Medical Center | Houston | Texas |
United States | Washington University in St. Louis | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PORT Delay | The initiation of PORT > 6 weeks (42 days) following definitive surgery for HNSCC. | 3 months | |
Secondary | Time-to-PORT | The number of days from the date of definitive surgery for HNSCC to the date of initiation of PORT. | 4 months | |
Secondary | Pre-Surgical consultation with radiation oncology | Consultation with a treating radiation oncologist prior to definitive surgery for HNSCC. | 1 month | |
Secondary | Pre-radiation therapy dental extractions | The removal of indicated carious/non-restorable teeth prior to or during the surgery for HNSCC. | 1 month | |
Secondary | Time to postoperative scheduling with radiation oncology | The time from definitive surgery to the placement of the postoperative referral (or follow-up appointment) with the treating radiation oncologist. | 3 months | |
Secondary | Time to postoperative appointment with radiation oncology | Time from definitive surgery to the attendance at an appointment with the treating radiation oncologist. | 3 months |
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