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NCT03077243 · ClinicalTrials.gov registry record · Phase 2
P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC
A Phase 2 study of Head and Neck Neoplasms and Carcinoma, Squamous Cell, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 195
- Enrollment target
- 4
- Study locations
NCT03077243: Completed Phase 2 study of Head and Neck Neoplasms and Carcinoma, Squamous Cell, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT03077243 is a Phase 2 study of Head and Neck Neoplasms and Carcinoma, Squamous Cell that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 195 participants, below the 257-participant average among 23 other Head and Neck Neoplasms trials with a reported enrollment target (24% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03077243, a Phase 2 study of Head and Neck Neoplasms and Carcinoma, Squamous Cell, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 195 participants
- Enrollment target
- 4
- Study locations
Study Summary
The primary objective of this study is to evaluate whether genomic based risk-stratification can be used in deciding whether to de-intensify in patients with Human Papillomavirus (HPV)-associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) with \> 10 pack years smoking history. Hypothesis: Patients with HPV-associated OPSCC, \> 10 pack years smoking history, and non-mutated p53 will have similar 2 year progression-free survival (PFS) as patients with \< 10 pack years smoking history.
Primary Outcome
PFS was assessed as the time from the first day of chemoradiation therapy (CRT) until disease progression. Disease progression was defined as biopsy proven tumor cells. Positron emission tomography / computerized tomography (PET/CT) was performed at week 10-16 (optimally at week 12) after completion of therapy. Biopsies were performed for subjects with imaging or clinical exam results suspicious for tumor. Clinical follow-up occurred and chest imaging was performed during the follow-up.
Conditions Studied
Interventions
- RADIATION Intensity Modulated Radiotherapy (IMRT)
- DRUG Cisplatin (or alternative)
- PROCEDURE Assessment for surgical evaluation
Study Locations (4)
Florida
- University of Florida - Gainesville
- University of Florida Proton Therapy Institute - Jacksonville
North Carolina
- University of North Carolina at Chapel Hill, Department of Radiation Oncology - Chapel Hill
- Rex Healthcare - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2016-12 |
| Est. Completion | 2022-12-14 |
| Phase | Phase 2 |
What the finished NCT03077243 record still lists
NCT03077243 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, below the 257-participant average among 23 other Head and Neck Neoplasms trials with a reported enrollment target (24% lower).
The record links to 3 conditions, with Head and Neck Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Intensity Modulated Radiotherapy (IMRT) is the first listed.
NCT03077243 reports a single indexed study location in Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03077243 about?
NCT03077243 is a clinical study titled "P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC". The primary objective of this study is to evaluate whether genomic based risk-stratification can be used in deciding whether to de-intensify in patients with Human Papillomavirus (HPV)-associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) with \> 10 pack years smoking history. Hypothesis: Patient...
What is the current status of trial NCT03077243?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2016-12. Estimated completion is 2022-12-14.
What conditions does trial NCT03077243 study?
This clinical trial studies the following conditions: Head and Neck Neoplasms, Carcinoma, Squamous Cell, Oropharyngeal Neoplasms.
What interventions are being tested in trial NCT03077243?
The interventions under investigation include: Intensity Modulated Radiotherapy (IMRT) (RADIATION), Cisplatin (or alternative) (DRUG), Assessment for surgical evaluation (PROCEDURE).
Who is sponsoring clinical trial NCT03077243?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03077243 being conducted?
This trial has 4 study locations across Florida, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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