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

NCT06307015 | Recruiting DMC

• 1 other identifier: 2023/ETH02441
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.What is the pathologic complete response rate in patients selected for radiation dose de-escalation and neck dissection?
2. 2.What is the correlation between MRI and FMISO PET assessment of hypoxia before and during RT?
3. 3.What are the acute and late toxicities in patients selected for radiation dose de-escalation?
4. 4.What are the quality of life scores in patients selected for radiation dose de-escalation?
5. 5.What are the local, regional and distant failure rates of patients selected for radiation dose de-escalation?

Conditions

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Keywords

Radiation therapy; De-escalation; FMISO PET; Hypoxia

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response

  Pathologic complete response in surgical neck dissection

  4 months after completion of radiation therapy

Secondary Outcomes (8)

• Correlation between MRI and FMISO PET assessment of hypoxia

  Baseline and after 2 weeks of radiation therapy

• Quality of Life of patients undergoing de-escalation radiation therapy

  Baseline, then 3 months post completion of treatment, then 3-monthly post to 2 years, then 6-monthly to 5 years

• Quality of Life of patients undergoing de-escalation radiation therapy

  Baseline, then 3 months post completion of treatment, then 3-monthly post to 2 years, then 6-monthly to 5 years

• Local control

  3-monthly to 2 years, 6-monthly to 5 years

• Regional control

  3-monthly to 2 years, 6-monthly to 5 years

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Standard of care treatment for patients undergoing definitive chemoradiation for oropharyngeal squamous cell carcinoma

Radiation: Standard of care

De-escalation

EXPERIMENTAL

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

Radiation: De-escalation

Interventions

De-escalation RADIATION

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

De-escalation

Standard of care RADIATION

Radiation therapy (70Gy) with concurrent platinum-based chemotherapy to oropharynx + neck

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
• 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

Sponsors & Collaborators

• Royal North Shore Hospital: lead

Study Sites (1)

Northern Sydney Cancer Centre, Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

RECRUITING

MeSH Terms

Conditions

Hypoxia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Anna Lawless

  Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

• Sarah Bergamin

  Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi Tsang

CONTACT

9463 1300; heidi.tsang@health.nsw.gov.au

Carolyn Kwong

CONTACT

carolyn.kwong@health.nsw.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncology Fellow & Principal Investigator

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 12, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2031
• Last Updated: July 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)