Actively Recruiting
De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE)
Led by Royal North Shore Hospital · Updated on 2025-07-30
25
Participants Needed
1
Research Sites
347 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Histologically confirmed cT1-2N1-2b oropharyngeal squamous cell carcinoma or cTxN1-2 carcinoma of unknown primary
- p16 positive (70% nuclear and cytoplasmic staining) and HPV positive (genotyping via PCR) tumors of the tonsil, base of tongue, glossotonsillar sulcus, or unknown primary site
- No contraindications to radiotherapy, platinum-based chemotherapy, or surgery
- No contraindications to PET/CT or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 (KPS > 70%)
- Ability to understand and willingness to sign a written informed consent document
You will not qualify if you...
- Women lactating, pregnant or of childbearing potential who are not willing to avoid pregnancy during the study
- History of severe renal disease (eGFR <20) that prevents tolerance of gadolinium contrast agents
- ECOG performance status 3 or higher
- Previous high dose radiation therapy to the head or neck
- Unwilling or unable to have PET/CT or MRI
- Geographically remote patients unable to comply with imaging schedule
- History of psychological illness affecting study understanding
- Significant cardiac or pulmonary disease including arrhythmias or COPD preventing tolerance of high flow oxygen
- Taking carbonic anhydrase inhibitors (acetazolamide)
- History of glaucoma
- Presence of any implant, foreign body, or device incompatible with 3T MRI or other MRI contraindications
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Trial Site Locations
Total: 1 location
1
Northern Sydney Cancer Centre, Royal North Shore Hospital
Saint Leonards, New South Wales, Australia, 2065
Actively Recruiting
Research Team
H
Heidi Tsang
CONTACT
C
Carolyn Kwong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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