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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06307015




Registration number
NCT06307015
Ethics application status
Date submitted
1/03/2024
Date registered
12/03/2024

Titles & IDs
Public title
De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE)
Scientific title
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)
Secondary ID [1] 0 0
2023/ETH02441
Universal Trial Number (UTN)
Trial acronym
DE-RADIATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HPV Positive Oropharyngeal Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - De-escalation
Treatment: Other - Standard of care

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


Treatment: Other: De-escalation
Surgical resection of primary oropharyngeal tumour followed by de-escalated radiation therapy (30Gy) with concurrent platinum-based chemotherapy to oropharynx + neck, followed by surgical neck dissection

Treatment: Other: Standard of care
Radiation therapy (70Gy) with concurrent platinum-based chemotherapy to oropharynx + neck
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pathologic complete response
Timepoint [1] 0 0
4 months after completion of radiation therapy
Secondary outcome [1] 0 0
Correlation between MRI and FMISO PET assessment of hypoxia
Timepoint [1] 0 0
Baseline and after 2 weeks of radiation therapy
Secondary outcome [2] 0 0
Quality of Life of patients undergoing de-escalation radiation therapy
Timepoint [2] 0 0
Baseline, then 3 months post completion of treatment, then 3-monthly post to 2 years, then 6-monthly to 5 years
Secondary outcome [3] 0 0
Quality of Life of patients undergoing de-escalation radiation therapy
Timepoint [3] 0 0
Baseline, then 3 months post completion of treatment, then 3-monthly post to 2 years, then 6-monthly to 5 years
Secondary outcome [4] 0 0
Local control
Timepoint [4] 0 0
3-monthly to 2 years, 6-monthly to 5 years
Secondary outcome [5] 0 0
Regional control
Timepoint [5] 0 0
3-monthly to 2 years, 6-monthly to 5 years
Secondary outcome [6] 0 0
Distant metastases
Timepoint [6] 0 0
3-monthly to 2 years, 6-monthly to 5 years
Secondary outcome [7] 0 0
Acute toxicities
Timepoint [7] 0 0
From date of commencement of RT, measured weekly during RT, fortnightly post treatment (up to 3 months post treatment)
Secondary outcome [8] 0 0
Late toxicities
Timepoint [8] 0 0
Commencing from 3 months post treatment and measured 3-monthly to 2 years, then 6-monthly to 5 years

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* Patients unwilling or unable to have PET/CT or MRI
* Geographically remote patients unable to agree to imaging schedule
* Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
* Patients with significant cardiac or pulmonary disease including cardiac arrythmias or Chronic Obstructive Pulmonary Disease (COPD) that are unable to tolerate high flow O2 for oxygen contrast.
* Patients taking carbonic anhydrase inhibitors (acetazolamide)
* History of glaucoma
* Any implant, foreign body, 3T MRI incompatible device, or other contraindication to MRI imaging

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2031
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Northern Sydney Cancer Centre, Royal North Shore Hospital - Saint Leonards
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anna Lawless
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carol Kwong
Address 0 0
Country 0 0
Phone 0 0
9463 1300
Fax 0 0
Email 0 0
carolyn.kwong@health.nsw.gov.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06307015