ClinConnect ClinConnect Logo
Search / Trial NCT04667585

Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx

Launched by DUKE UNIVERSITY · Dec 8, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Pet Ct

ClinConnect Summary

This clinical trial is studying a new approach to treating HPV-related cancers of the oropharynx, which is the part of the throat just behind the mouth. The researchers want to see if they can safely reduce the amount of radiation therapy some patients receive by using a special imaging technique called 18FDG-PET/CT during treatment. By identifying patients who respond well to the initial treatment, they hope to find out if lower doses of radiation can still be effective, potentially leading to fewer side effects for patients.

To participate in this trial, you must be at least 18 years old and have been diagnosed with a specific type of throat cancer that tests positive for HPV. It's important that you haven't received any prior chemotherapy for this cancer, and you should have a good overall health status. During the trial, participants will receive the standard treatment along with the imaging tests, and the study will track their health outcomes over time. This research is currently recruiting patients, and it could offer a promising option for those diagnosed with this type of cancer.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Histologic documentation of squamous cell carcinoma of the oropharynx with p16-positive immunohistochemical staining and/or positive HPV in situ hybridization (ISH) and/or positive HPV PCR
  • Stage I-III (AJCC 8th edition) with plan for concurrent chemotherapy per standard of care treatment
  • Zubrod/ECOG score of 0-1
  • Weight loss \<10% in the 3 months prior to diagnosis
  • ≥ 18 years of age
  • No prior chemotherapy for their current cancer diagnosis
  • Exclusion Criteria:
  • Prior radiotherapy to the head and neck
  • Medical contraindications to radiation therapy
  • Absence of gross disease on imaging prior to beginning radiation therapy
  • Distant metastatic disease
  • Medical contraindication to PET/CT
  • History of active cancer other than non-melanoma skin cancer within the last 5 years

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Raleigh, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

David Brizel, MD

Principal Investigator

DUHS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials