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

Oropharynx Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04667585
• Other study ID #: Pro00105899
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: April 2027

Study information

• Verified date: June 2024
• Source: Duke University
• Contact: Heather Franklin, BSN, RN, OCN
• Phone: (919) 668-3726
• Email: heather.mccullough[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oropharyngeal Neoplasms
• Oropharynx Cancer

Intervention

Radiation:
• De-escalated radiation dose
Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced
• Standard radiation dose
Standard dose of radiation applied to remaining radiation therapy when favorable PET-CT signature is not produced

Other:
• 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)
The CT scan - also called computerized tomography or just CT - combines a series of X-ray views taken from many different angles to produce cross-sectional images of the bones and soft tissues inside the body. CT scans in planning radiation therapy are standard of care. A PET is a highly specialized imaging technique that uses short-lived radioactive substances (such as FDG a simple sugar labeled with a radioactive atom) to produce three-dimensional colored images of those substances functioning within the body. These images are called PET scans and the technique is termed PET scanning. PET scanning provides information about the body's chemistry not available through other procedures. Unlike CT or MRI (magnetic resonance imaging), techniques that look at anatomy or body form, PET studies metabolic activity or body function.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Duke Raleigh Hospital	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	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	from initiation of radiation therapy through study completion, an average of 2 years
Secondary	locoregional progression-free survival	as measured by abstraction from the medical record	from initiation of radiation therapy through study completion, an average of 2 years
Secondary	distant disease-free survival	as measured by abstraction from the medical record	from initiation of radiation therapy through study completion, an average of 2 years
Secondary	overall survival	as measured by abstraction from the medical record	from initiation of radiation therapy through study completion, an average of 2 years
Secondary	progression free survival correlation in PET/CT responders versus PET/CT non-responders	as measured by the difference in median Kaplan-Meyer values	2 years
Secondary	Acute adverse events	as measured by the number of participants who experience dermatitis, mucositis, xerostomia, dysphagia, dysgeusia, neutropenia, thrombocytopenia, nausea, vomiting, renal toxicity, and hearing loss	7 weeks
Secondary	Long term adverse events	as measured by the number of participants who experience xerostomia, dysphagia, dysgeusia, trismus, lymphedema, superficial soft tissue fibrosis, hypothyroidism and periodontal disease	2 years