Actively Recruiting
De-escalation of Radiation Dose in HPV-associated Oropharyngeal Squamous Cell Carcinoma Using FMISO PET and MRI as Non-Invasive Hypoxia Biomarkers
Led by Royal North Shore Hospital · Updated on 2025-07-30
25
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying HPV-associated oropharyngeal squamous cell carcinoma that shows no hypoxia on FMISO PET scans to see if treatment with a lower radiation dose is effective. The trial aims to find out the rate of complete tumor response after reduced radiation, how MRI and FMISO PET scans compare in detecting tumor oxygen levels, the side effects of reduced radiation, quality of life after treatment, and rates of cancer recurrence locally and in other areas. Patients with specific tumor stages will have surgery followed by either standard or lower radiation therapy based on FMISO PET results. Participants will be grouped by tumor oxygen levels shown on FMISO PET scans before and during radiation. Those without hypoxia will receive a lower radiation dose (30Gy) with concurrent cisplatin chemotherapy, followed by mandatory neck dissection 3-4 months after radiation to assess tumor response. Patients with hypoxic tumors will receive standard radiation (70Gy) with chemotherapy. Additional MRI scans will be done but will not affect treatment decisions. All patients will have a PET/CT scan three months after radiation as part of usual care. During the study, participants will undergo various imaging procedures including FMISO PET/CT, MRI before and during radiation, and FDG-PET/CT after treatment. Researchers will track tumor response through pathology after surgery, measure quality of life regularly up to five years, monitor tumor control in the head and neck area, and record side effects from treatment both during and after radiation. Follow-up will continue for a minimum of five years to assess long-term outcomes.
CONDITIONS
Brief 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 greater than 18 years
- Confirmed HPV-associated oropharyngeal squamous cell carcinoma or carcinoma of unknown primary with cT1-2N1-2b or cTxN1-2 staging
- Tumors must be p16 positive and HPV positive by specified tests
- No contraindications to radiotherapy, platinum chemotherapy, or surgery
- No contraindications to PET/CT or MRI imaging
- ECOG performance status 0 to 2 (KPS greater than 70%)
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Women who are pregnant, lactating, or of childbearing potential unwilling to avoid pregnancy
- History of severe kidney disease (eGFR less than 20) preventing use of contrast agents
- ECOG performance status 3 or higher
- Prior high dose radiation therapy to head or neck
- Unwilling or unable to undergo PET/CT or MRI
- Patients living remotely unable to comply with imaging schedule
- Psychological conditions interfering with study understanding
- Significant heart or lung diseases preventing oxygen contrast use
- Use of carbonic anhydrase inhibitors (acetazolamide)
- History of glaucoma
- Presence of implants or devices incompatible with 3T MRI or other MRI contraindications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - A few days to 1 week
Participants undergo surgical resection or biopsy of the primary tumor site and lymph nodes as applicable.
1 visit (in-person)
Duration - Up to 1 week before radiation therapy
Participants undergo FMISO PET/CT and MRI scans before radiation therapy to assess tumor hypoxia and other imaging biomarkers.
1 visit (in-person)
Duration - Approximately 6 to 7 weeks
Participants receive radiation therapy with concurrent platinum-based chemotherapy. Radiation dose is de-escalated to 30Gy for participants without tumor hypoxia or with resolved hypoxia, or standard 70Gy for others. FMISO PET/CT and MRI are repeated during treatment to reassess hypoxia.
Weekly visits during radiation therapy for imaging and treatment
Duration - 1 to 2 weeks
Participants in the de-escalation group undergo mandatory ipsilateral neck dissection within 3 to 4 months after completing radiation therapy to assess pathologic response.
1 to 2 visits (in-person)
Duration - Several weeks
Participants are monitored for recovery and surgical outcomes following neck dissection.
Approximately 6 post-operative visits
Duration - Up to 5 years post treatment
Participants are followed up regularly for up to 5 years to monitor quality of life, local and regional control, distant metastases, and toxicities.
Visits every 3 months for 2 years, then every 6 months up to 5 years
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
C
Carolyn Kwong
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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