Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Conditions Studied

Head and Neck Neoplasms Carcinoma, Squamous Cell Oropharyngeal Neoplasms

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

FieldValue
Enrollment Target 195 participants
Start Date 2016-12
Est. Completion 2022-12-14
Phase Phase 2

Sponsor

UNC Lineberger Comprehensive Cancer Center

366 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03077243

The ClinicalTrials.gov registry entry for NCT03077243 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 257-participant average among 23 other Head and Neck Neoplasms trials with a reported enrollment target (24% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 2 distinct geographic areas - top geographies include 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.

Learn More About Clinical Trials

Similar trials for Head and Neck Neoplasms

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Head and Neck Neoplasms

All registered trials for this condition

Carcinoma, Squamous Cell

All registered trials for this condition

Florida

All trials with a study site in Florida

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.