Status:
COMPLETED
Single-arm Phase II Study of NDURE for Patients With HNC
Lead Sponsor:
Medical University of South Carolina
Conditions:
Cancer of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will evaluate whether a new patient navigation intervention can decrease delays starting post-operative radiation therapy after surgery for white and African-American head and neck cancer p...
Detailed Description
This study will evaluate the feasibility, acceptability, preliminary clinical impact, and preliminary behavioral impact of NDURE (Navigation for Disparities and Untimely Radiation thErapy), our multi-...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age \> 18 years at the time of screening
- Histologically or pathologically confirmed invasive squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx (p16 positive, negative, or unknown), hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity.
- 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.
- No prior exposure to radiation therapy, with or without concurrent chemotherapy, for treatment of HNSCC in the definitive or adjuvant therapy settings
- Plan for curative intent surgery at MUSC
- Plan for PORT (at MUSC or non-MUSC) with or without concurrent chemotherapy following curative intent surgery
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Self-identified Hispanic ethnicity
- Presence of cognitive impairment that precludes participation as determined by oncology provider
- Prior radiation therapy for HNC
- 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 final pathologic evaluation of adverse features and AJCC pathologic stage grouping
Exclusion
Key Trial Info
Start Date :
June 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03821064
Start Date
June 3 2019
End Date
November 21 2019
Last Update
February 1 2021
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425