Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04667585

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

The purpose of this study is to use intra-treatment 18FDG-PET/CT during definitive radiation therapy for human papillomavirus (HPV)-related oropharyngeal cancer (OPC) as an imaging biomarker to identify and select patients with a favorable response for chemoradiation dose de-escalation. This study will prospectively evaluate the clinical outcomes for patients undergoing dose de-escalation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Oropharynx Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center, Durham, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

De-escalated radiation dose

Radiation

Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced

Standard radiation dose

Radiation

Standard dose of radiation applied to remaining radiation therapy when favorable PET-CT signature is not produced

18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)

Other

The CT scan - also called computerized tomography or just CT - combines a series of X-ray views taken from many different angles to produce cross-sectional images of the bones and soft tissues inside the body. CT scans in planning radiation therapy are standard of care. A PET is a highly specialized imaging technique that uses short-lived radioactive substances (such as FDG a simple sugar labeled with a radioactive atom) to produce three-dimensional colored images of those substances functioning within the body. These images are called PET scans and the technique is termed PET scanning. PET scanning provides information about the body's chemistry not available through other procedures. Unlike CT or MRI (magnetic resonance imaging), techniques that look at anatomy or body form, PET studies metabolic activity or body function.

Other names: 18 FDG-PET/CT

Primary outcomes

  1. Progression-free survival

    Time frame: from initiation of radiation therapy through study completion, an average of 2 years

    defined as the time between initiation of radiation treatment and the first documented recurrence of disease or death due to any cause as measured by medical record abstraction

Secondary outcomes

  1. locoregional progression-free survival

    Time frame: from initiation of radiation therapy through study completion, an average of 2 years

    as measured by abstraction from the medical record

  2. distant disease-free survival

    Time frame: from initiation of radiation therapy through study completion, an average of 2 years

    as measured by abstraction from the medical record

  3. overall survival

    Time frame: from initiation of radiation therapy through study completion, an average of 2 years

    as measured by abstraction from the medical record

  4. progression free survival correlation in PET/CT responders versus PET/CT non-responders

    Time frame: 2 years

    as measured by the difference in median Kaplan-Meyer values

  5. Acute adverse events

    Time frame: 7 weeks

    as measured by the number of participants who experience dermatitis, mucositis, xerostomia, dysphagia, dysgeusia, neutropenia, thrombocytopenia, nausea, vomiting, renal toxicity, and hearing loss

  6. Long term adverse events

    Time frame: 2 years

    as measured by the number of participants who experience xerostomia, dysphagia, dysgeusia, trismus, lymphedema, superficial soft tissue fibrosis, hypothyroidism and periodontal disease

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx Using Metabolic Signature From Interim 18FDG-PET/CT

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Dec 14, 2020
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.