De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE)

Launched by ROYAL NORTH SHORE HOSPITAL · Mar 6, 2024

Keywords

ClinConnect Summary

The DE-RADIATE trial is a study focusing on a specific type of throat cancer known as HPV-positive oropharyngeal squamous cell carcinoma. The main goal of the trial is to find out if patients with tumors that are not low in oxygen can be treated successfully with a lower dose of radiation therapy. Patients who qualify for this study will have surgery to remove their tumor, and depending on the results of a special imaging test called FMISO PET, they may receive either the standard high dose of radiation or a reduced dose along with chemotherapy. Researchers will then monitor how well the treatment works and the quality of life for patients who received the lower dose.

To be eligible for this trial, participants need to be over 18 years old and have a confirmed diagnosis of HPV-positive oropharyngeal cancer. They should also be in relatively good health and able to understand the study requirements. Throughout the trial, participants will have regular check-ups and tests to assess their response to treatment and any side effects. This study is currently not recruiting participants, but it aims to improve treatment options and outcomes for patients with this type of cancer.

Gender

ALL

Eligibility criteria

• 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