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

Duke University

Status: Enrolling

Conditions: Oropharynx Cancer

Treatments: Radiation: Standard radiation dose; Radiation: De-escalated radiation dose; Other: 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04667585

Pro00105899

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Interim PET-CT with dose de-escalation

Experimental group

Description:

Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.

Treatment:

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

Radiation: De-escalated radiation dose

Interim PET-CT with standard radiation

Active Comparator group

Treatment:

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

Radiation: Standard radiation dose