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NCT04667585 | RECRUITING | Oropharynx Cancer

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

Duke University

Brief Summary:

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.

Condition or disease

Oropharynx Cancer

Intervention/treatment

De-escalated radiation dose

Standard radiation dose

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

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : SINGLE
Primary Purpose : OTHER
Official Title : Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx Using Metabolic Signature From Interim 18FDG-PET/CT
Actual Study Start Date : 2021-04-12
Estimated Primary Completion Date : 2028-01
Estimated Study Completion Date : 2028-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx

Location Details

NCT04667585

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How to Participate

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Locations

RECRUITING

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

RECRUITING

United States, North Carolina

Duke Raleigh Hospital

Raleigh, North Carolina, United States, 27609