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PRESERVE: Radiation Volume Effects for Oral Cavity Squamous Cell Carcinoma

This study, called PRESERVE, is for people who have had surgery for oral cavity squamous cell carcinoma (a type of mouth cancer). It compares two ways of giving radiation therapy after surgery. One group will receive radiation to all areas that were surgically treated, while the other group will receive radiation that avoids a specific area of the neck (pN0 neck). The main goal is to see if avoiding radiation to this specific neck area can improve your quality of life, which includes how well you can swallow. Researchers will also track how many people experience cancer returning in the pN0 hemi-neck over five years. This study aims to enroll 90 participants.

Study design
This is a randomized study, meaning participants will be assigned to one of two treatment groups by chance. It plans to enroll 90 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a total of 5 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03997643

Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial

Recruiting
PHASE2Ages 18+InterventionalTreatment
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
~90 participants
Updated 2023-08-03 on ClinicalTrials.gov
What's tested:Radiotherapy to all dissected areasOmit radiation to pN0 neck

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Regional failure in the pN0 hemi-neck (s)
Measured over Baseline to 5 years

Conditions

Head and Neck Cancer

Explore related trials

Oral Cavity Squamous Cell Carcinoma

Where it's being run

8 sites across 8 states
Florida1
Ontario1
Quebec1
County Cork1
County Galway1
Dublin1
Leinster1
United Kingdom1

Who to contact

Noah Kalman, MD
[email protected]
786-596-2000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Regional failure in the pN0 hemi-neck (s)Baseline to 5 years

    Rate of relapse in the pN0 neck in Arm 2 compared to historical controls