RECRUITING

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

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Oropharynx CancerPET-CT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-04-12
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04667585

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Stage I-III (AJCC 8th edition) with plan for concurrent chemotherapy per standard of care treatment
  3. * Zubrod/ECOG score of 0-1
  4. * Weight loss \<10% in the 3 months prior to diagnosis
  5. * ≥ 18 years of age
  6. * No prior chemotherapy for their current cancer diagnosis
  1. * Prior radiotherapy to the head and neck
  2. * Medical contraindications to radiation therapy
  3. * Absence of gross disease on imaging prior to beginning radiation therapy
  4. * Distant metastatic disease
  5. * Medical contraindication to PET/CT
  6. * History of active cancer other than non-melanoma skin cancer within the last 5 years

Contacts and Locations

Study Contact

Heather Franklin, BSN, RN, OCN
CONTACT
(919) 668-3726
heather.mccullough@duke.edu

Principal Investigator

David Brizel, MD
PRINCIPAL_INVESTIGATOR
DUHS

Study Locations (Sites)

Duke University Medical Center
Durham, North Carolina, 27710
United States
Duke Raleigh Hospital
Raleigh, North Carolina, 27609
United States

Collaborators and Investigators

Sponsor: Duke University

  • David Brizel, MD, PRINCIPAL_INVESTIGATOR, DUHS

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-12
Study Completion Date2027-04

Study Record Updates

Study Start Date2021-04-12
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • PET-CT

Additional Relevant MeSH Terms

  • Oropharynx Cancer