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

Not Applicable

Recruiting

• Conditions: Oropharynx Cancer
• Interventions: Radiation: De-escalated radiation dose; Radiation: Standard radiation dose; Other: 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)

• Registration Number: NCT04667585
• Lead 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-14
• Study Start: 2021-04-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interim PET-CT with standard radiation	18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)	-
Interim PET-CT with dose de-escalation	De-escalated radiation dose	Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.
Interim PET-CT with standard radiation	Standard radiation dose	-
Interim PET-CT with dose de-escalation	18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)	Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	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 Outcome Measures

Name	Time	Method
locoregional progression-free survival	from initiation of radiation therapy through study completion, an average of 2 years	as measured by abstraction from the medical record
overall survival	from initiation of radiation therapy through study completion, an average of 2 years	as measured by abstraction from the medical record
Long term adverse events	2 years	as measured by the number of participants who experience xerostomia, dysphagia, dysgeusia, trismus, lymphedema, superficial soft tissue fibrosis, hypothyroidism and periodontal disease
progression free survival correlation in PET/CT responders versus PET/CT non-responders	2 years	as measured by the difference in median Kaplan-Meyer values
distant disease-free survival	from initiation of radiation therapy through study completion, an average of 2 years	as measured by abstraction from the medical record
Acute adverse events	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

Trial Locations

Locations (2)

Duke Raleigh Hospital; 🇺🇸 Raleigh, North Carolina, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States