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

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.

Conditions

Oropharynx Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Oropharynx Cancer
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

Raleigh

Duke Raleigh Hospital, Raleigh, North Carolina, United States, 27609

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

David Brizel, MD, PRINCIPAL_INVESTIGATOR, DUHS

Study Record Dates

2027-04