Lower-dose radiation for non-hypoxic HPV-positive oropharyngeal cancer guided by FMISO PET

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients with early-stage HPV-positive oropharyngeal cancer or nodal carcinoma of unknown primary will undergo surgical sampling or biopsy and baseline FMISO PET/CT to look for tumor hypoxia. FMISO PET is repeated after 5–10 fractions of radiation to detect persistent or resolving hypoxia, and patients without pre-treatment hypoxia or with intra-treatment resolution are assigned to a de-escalated radiation regimen (total 30 Gy) while others receive standard definitive dosing. The trial measures pathologic complete response after neck dissection, correlates FMISO PET with MRI hypoxia assessment, and tracks acute and late toxicities, quality of life, and local/regional/distant failure rates. Imaging-based hypoxia selection is used to personalise radiation dose with the goal of reducing treatment morbidity without compromising control.

Why it matters

Who can join: the full rules

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

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

Where it's running

• Northern Sydney Cancer Centre, Royal North Shore Hospital
  Saint Leonards, New South Wales, Australia Recruiting

Study contacts

• Principal investigator: Anna Lawless — Royal North Shore Hospital
• Study coordinator: Heidi Tsang
• Email: heidi.tsang@health.nsw.gov.au
• Phone: 9463 1300

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intranasal WSK-IM05 vaccine plus tislelizumab before surgery for HPV‑positive oropharyngeal cancer

  This phase I trial will see if an intranasal WSK‑IM05 vaccine given with the PD‑1 drug tislelizumab before surgery helps people with resectable HPV‑positive oropharyngeal cancer.

  Recruiting Phase 1 West China Hospital · Chengdu, Sichuan · NCT07565740

• Lowering nodal and primary tumor radiation dose in HPV-positive oropharyngeal cancer

  This phase II study tests whether reducing radiation doses to regions without visible cancer, while keeping the main tumor dose the same, can treat HPV-positive OPSCC with fewer side effects.

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• Selective dose reduction of neck radiation in HPV-associated oropharyngeal cancer

  This trial tests whether lowering radiation doses to certain neck lymph nodes or gross disease areas is safe and can reduce side effects for adults with HPV-related oropharyngeal cancer.

  Recruiting at 4 sites Phase 2 University of Maryland, Baltimore · Baltimore, Maryland and 3 other locations · NCT07418034

• CUE-101 with pembrolizumab for locally advanced HPV‑16 positive oropharyngeal cancer

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• Sacituzumab govitecan plus cetuximab for recurrent or metastatic head and neck squamous cell cancer

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  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07063212

• BVAC-E6E7 immunotherapy for HPV-positive head and neck cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.