Comparing radiation therapy methods for preserving swallowing in oral cavity cancer patients

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 randomized treatment study aims to compare the quality of life in patients with resected oral cavity squamous cell carcinoma who receive either standard radiation therapy or targeted radiation therapy. The study will involve 90 patients, randomized in a 2:3 ratio between the two treatment arms. Patients will be monitored for a total of 5 years to assess the impact of the different radiation approaches on their swallowing function and overall quality of life. The findings are intended to provide high-level evidence to guide treatment decisions for this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Willing to provide informed consent
* ECOG performance status 0-2
* Histologically confirmed, resected oral cavity squamous cell carcinoma with at least ipsilateral selective neck disection
* Patient has pathological features that are indications for PORT: positive or close (≤ 3 mm) margin, presence of LVI or PNU, pT3 or pT4 disease, positive lymph nodes, and PORT is recommended by treating physician
* Pathologically lympth node negative in at least one dissected hemi-neck with at least 10 nodes recovered in each pN0 hemi-neck

Exclusion Criteria:

* Serious medical comorbidities or other contraindications to radiotherapy
* Prior history of head and neck cancer within 5 years
* Any other active invasive malignancy, except non-melanotic skin cancers
* Prior head and neck radiation at any time
* Prior oncologic head and neck surgery in the oral cavity or neck
* Metastatic disease
* Locoregional disease recurrence identified following surgical resection but prior to the start of radiotherapy
* Inability to attend full course of radio therapy or follow-up visits
* Unable or unwilling to complete QoL questionnaires
* Pregnant or lactating women

Where it's running

• Miami Cancer Institute
  Miami, Florida, United States Recruiting
• London Regional Cancer Program
  London, Ontario, Canada Recruiting
• Chum
  Montreal, Quebec, Canada Recruiting
• Cork University Hospital
  Wilton, County Cork, Ireland Recruiting
• University Hospital Galway, Newcastle Road
  Galway, County Galway, Ireland Recruiting
• St. Luke's Radiation Oncology Network
  Rathgar, Dublin, Ireland Recruiting

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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.