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De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE)
Sponsor: Royal North Shore Hospital
Summary
The goal of this prospective clinical trial is to determine if HPV-associated oropharyngeal squamous cell carcinoma that is non-hypoxic on FMISO PET can be successfully treated with a lower dose of radiation therapy. The main questions it aims to answer are: 1. What is the pathologic complete response rate in patients selected for radiation dose de-escalation and neck dissection? 2. What is the correlation between MRI and FMISO PET assessment of hypoxia before and during RT? 3. What are the acute and late toxicities in patients selected for radiation dose de-escalation? 4. What are the quality of life scores in patients selected for radiation dose de-escalation? 5. What are the local, regional and distant failure rates of patients selected for radiation dose de-escalation? Patients with cT1-2N1-2b (AJCC 7th edition) oropharyngeal tumours will undergo surgical resection of the primary tumour. Following this, they will be allocated to standard radiation therapy (70Gy with concurrent cisplatin chemotherapy) or de-escalation radiation therapy (30Gy with concurrent cisplatin chemotherapy) based on the results of FMISO PET. Patients with non-hypoxic tumours at baseline OR after two weeks of radiation therapy will be allocated to the de-escalated group. 3-4 months after completion of radiation therapy, all patients in the de-escalated group will undergo mandatory neck dissection to assess pathologic response. Researchers will assess the pathologic response rate after surgery in the de-escalation group. They will also compare the outcomes (oncological outcomes and quality of life) between the group receiving the standard treatment (70Gy) and the group receiving de-escalated radiation therapy (30Gy).
Official title: De-escalation of Radiation Dose in HPV-associated Oropharyngeal Squamous Cell Carcinoma Utilising FMISO PET and Magnetic Resonance Imaging as Non-Invasive Biomarkers of Hypoxia (DE-RADIATE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2025-04-01
Completion Date
2031-12
Last Updated
2025-07-30
Healthy Volunteers
No
Interventions
De-escalation
Surgical resection of primary oropharyngeal tumour followed by de-escalated radiation therapy (30Gy) with concurrent platinum-based chemotherapy to oropharynx + neck, followed by surgical neck dissection
Standard of care
Radiation therapy (70Gy) with concurrent platinum-based chemotherapy to oropharynx + neck
Locations (1)
Northern Sydney Cancer Centre, Royal North Shore Hospital
Saint Leonards, New South Wales, Australia