N/A
Completed N=176
Navigation vs Usual Care for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC
Source: ClinicalTrials.gov NCT04030130 ↗Enrolled (actual)
176
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Delay Initiating Postoperative Radiation Therapy (PORT) — 14; 46 Participants
Summary
Head and neck cancer squamous cell carcinoma (HNSCC) is a disease with poor survival, especially for African Americans, despite intense treatment including surgery, radiation, and chemotherapy. Delays between surgery and the start of postoperative radiation therapy (PORT) are common, cause excess mortality, and contribute to worse survival in African Americans. Our research team has developed NDURE (Navigation for Disparities and Untimely Radiation thErapy), a novel theory-based patient navigation (PN) intervention to decrease delays and racial disparities starting PORT. In this single-site, open label, parallel-group, randomized controlled trial of adults with surgically-managed, locally advanced HNSCC, will be randomized to NDURE versus usual care to assess the preliminary clinical impact of NDURE on delays and racial disparities starting PORT after surgery for HNSCC. The investigators will collect information about the rate of PORT delay, racial disparities in the rate of PORT delay, and completion rate of key cancer care processes. Participants will also complete validated questionnaires at baseline and post-intervention to understand the theoretical constructs underlying NDURE . Post-intervention, patients and providers will undergo interviews to obtain in-depth understanding of the content, format, timing, and delivery of NDURE to optimize the intervention in preparation for a future multi-site study. NDURE could provide the first effective intervention to improve the delivery of timely, equitable PORT after HNC surgery, thereby improving survival for patients with HNC, decreasing racial disparities in mortality, and developing new standards of clinical care.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delay Initiating Postoperative Radiation Therapy (PORT) |
14; 46 | — |
| SECONDARY Time Interval Between Surgery and the Start of PORT |
39; 47 | — |
| SECONDARY Treatment Package Time |
84; 89 | — |
| SECONDARY Racial Differences in Delays in Starting PORT |
3; 14; 11; 32 | — |
| SECONDARY Racial Differences in Time Interval Between Surgery and the Start of PORT |
38; 55; 39; 45 | — |
| SECONDARY Racial Differences in Treatment Package Time |
83; 93; 84; 88 | — |
| SECONDARY Percent of Patients With Pre-surgical Radiation Consultation |
47; 31 | — |
| SECONDARY Percent of Patients With Pre-Radiation Therapy Dental Extractions |
44; 31 | — |
| SECONDARY Time From Surgery to PORT Referral |
8; 16 | — |
| SECONDARY Time From Surgery to Postoperative Appointment With Radiation Oncology |
20.0; 24.5 | — |
Eligibility Criteria
Inclusion Criteria
Patient and disease characteristics
- Age > 18 years at the time of screening
- Histologically or pathologically confirmed invasive SCC (or histologic variant) of the oral cavity, oropharynx (p16 positive, negative, or unknown), hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity.
a. In situations in which the patient fulfills all other inclusion criteria but the biopsy shows SCC in-situ or moderate/severe dysplasia (without definitive evidence of invasive SCC), but the patient is scheduled to undergo curative intent surgery by the treating oncologic surgeon due to clinical suspicion of invasive SCC, the diagnosis of SCC-in situ or moderate/severe dysplasia is sufficient to full the pathologic diagnosis enrollment criterion.
- 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.
- At screening, AJCC clinical stage grouping should be determined based on a combination of physical exam, diagnostic evaluation with cross sectional imaging of the neck (computerized tomography (CT) and/or magnetic resonance imaging (MRI)) and/or 18-F-fluoro-deoxyglucose positron emission tomography (FDG PET) CT within 30 days
- In situations in which the patient fulfills all other inclusion criteria but the biopsy shows SCC in-situ or moderate/severe dysplasia (without definitive evidence of invasive SCC), but would otherwise have an appropriate clinical stage grouping as defined in criterion 5, the diagnosis of SCC-in situ or moderate/severe dysplasia is sufficient to full the staging enrollment criterion.
- No prior exposure to radiation therapy, with or without concurrent chemotherapy, for treatment of HNSCC in the definitive or adjuvant therapy settings
Surgery and adjuvant therapy eligibility
- Plan for curative intent surgery at MUSC
a. At screening, plan for curative intent surgical resection of the HNSCC at MUSC must be deemed likely by the treating surgeon and/or multidisciplinary tumor board, which must include a fellowship-trained head and neck oncologic surgeon
- Plan for PORT (at MUSC or non-MUSC) with or without concurrent chemotherapy following curative intent surgery a. At screening, plan for adjuvant therapy following curative intent surgical resection of the HNSCC at MUSC must be deemed likely by the treating surgeon and/or multidisciplinary tumor board, which must include a fellowship-trained head and neck oncologic surgeon, based on the clinical expectation of at least one of the following adverse features on final pathologic evaluation: extranodal extension (ENE), pT3 or pT4 primary, N2 or N3 nodal disease, nodal disease in levels IV or V, perineural invasion (PNI), or lymphovascular invasion (LVI)
Exclusion Criteria
- Self-identified Hispanic ethnicity
- Presence of cognitive impairment that precludes participation
- Synchronous untreated malignancy
- Failure to undergo curative intent surgery at MUSC
- Lack of indication for PORT (with or without concurrent chemotherapy) per National Comprehensive Cancer Network (NCCN) Guidelines based on the presence of at least one of the following adverse features on final pathologic evaluation: ENE, positive margin, pT3 or pT4 primary, N2 or N3 nodal disease, nodal disease in levels IV or V, PNI, or LVI
Data sourced from ClinicalTrials.gov (NCT04030130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.