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New treatment option for HPV Positive Oropharyngeal Squamous Cell Carcinoma
Official title De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE)
ClinicalTrials.gov ID: NCT06307015
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- No contraindications to radiotherapy, platinum-based chemotherapy or surgery
- No contraindications to PET/CT or MRI
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Saint Leonards, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Leonards, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.