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)

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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) tumours of the tonsil, base of tongue, glossotonsillar sulcus, or unknown primary site (suspected mucosal origin).

• 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

Locations
Other Locations
Australia
Northern Sydney Cancer Centre, Royal North Shore Hospital
RECRUITING
Saint Leonards
Contact Information
Primary
Heidi Tsang
heidi.tsang@health.nsw.gov.au
9463 1300
Backup
Carolyn Kwong
carolyn.kwong@health.nsw.gov.au
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2031-12
Participants
Target number of participants: 25
Treatments
Active_comparator: Standard of care
Standard of care treatment for patients undergoing definitive chemoradiation for oropharyngeal squamous cell carcinoma
Experimental: De-escalation
De-escalated radiation therapy for patients undergoing surgery to the primary site followed by chemoradiation to the primary site and neck for oropharyngeal squamous cell carcinoma
Related Therapeutic Areas
Sponsors
Leads: Royal North Shore Hospital

This content was sourced from clinicaltrials.gov