protocolSection identificationModule nctId: NCT06307015, orgStudyIdInfo id: 2023/ETH02441, briefTitle: De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE), acronym: DE-RADIATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2031-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Royal North Shore Hospital, class: OTHER, descriptionModule briefSummary: 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)., conditionsModule conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: De-escalation, interventions name: Standard of care, outcomesModule primaryOutcomes measure: Pathologic complete response, secondaryOutcomes measure: Correlation between MRI and FMISO PET assessment of hypoxia, secondaryOutcomes measure: Quality of Life of patients undergoing de-escalation radiation therapy, secondaryOutcomes measure: Quality of Life of patients undergoing de-escalation radiation therapy, secondaryOutcomes measure: Local control, secondaryOutcomes measure: Regional control, secondaryOutcomes measure: Distant metastases, secondaryOutcomes measure: Acute toxicities, secondaryOutcomes measure: Late toxicities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northern Sydney Cancer Centre, Royal North Shore Hospital, city: Saint Leonards, state: New South Wales, zip: 2065, country: Australia, contacts name: Carol Kwong, role: CONTACT, phone: 9463 1300, email: carolyn.kwong@health.nsw.gov.au, contacts name: Anna Lawless, role: PRINCIPAL_INVESTIGATOR, contacts name: Sarah Bergamin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.82344, lon: 151.19836, hasResults: False