Effects of Delayed Elective Radiotherapy on Head and Neck Cancer Biomarkers

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

This study investigates the impact of delayed elective radiotherapy on biomarker development in patients with newly diagnosed head and neck squamous cell carcinoma (HNSCC) undergoing curative treatment. Up to 40 patients will be randomized to receive either conventional radiotherapy or a reversed two-phase treatment with delayed irradiation. Participants will undergo functional MRI scans and biopsies at baseline and during treatment to assess changes in tumor response and immune biomarkers. The study aims to enhance understanding of treatment effects on tumor biology.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \>/= 18 years
* Histologically proven Head and Neck Squamous Cell carcinoma
* Primary or nodal disease \> 3cm for biomarker imaging
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Planned for curative surgery or (chemo)radiotherapy
* Willingness to undergo repeat MRI imaging
* Able to receive and understand verbal and written information regarding study and able to -give written informed consent
* Adequate renal function: Calculated creatinine clearance \>/= 30ml/min
* Be able to lie comfortably on back for 1 hour

Exclusion Criteria:

* Currently participating in another study that requires standard of care radiotherapy
* More than one contralateral nodal level requiring treatment in phase I
* As judged by investigator evidence of systemic disease that makes unsuitable for study
* As judged by investigator, it is deemed unsafe or medically inadvisable to conduct repeat biopsies
* Contra-indication for serial MRI scans
* Previous solid tumor treated within last 5 years that investigator feels makes unsuitable for study
* Pregnancy
* History of gadolinium contrast allergy
* Non-reversible clotting abnormality
* History of significant respiratory disease

Where it's running

• Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Andrew McPartlin, MD
• Email: andrew.mcpartlin@rmp.uhn.ca
• Phone: 416-946-2132

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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.