De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal North Shore Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Women lactating, pregnant or of childbearing potential who are not willing to avoid pregnancy during the study
Patients with a history of severe renal disease(s) (eGFR <20) than cannot tolerate gadolinium chelate contrast agents.)
ECOG ≥ 3
Previous high dose radiation therapy to the head or neck
Trial design
Treatments tested in this trial
- De-escalation
- Standard of care
Treatment groups
25 Participants
are divided into 2 treatment groupsLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Northern Sydney Cancer Centre, Royal North Shore HospitalRecruiting2065, Saint Leonards, New South Wales
Australia
AustraliaSponsors and collaborators
Source ClinicalTrials.gov