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

  • STATUS
    Recruiting
  • End date
    Sep 8, 2026
  • participants needed
    90
  • sponsor
    Lawson Health Research Institute
Updated on 4 October 2022
carcinoma
squamous cell carcinoma
dental caries
squamous cell carcinoma of the oral cavity
mouth cancer

Summary

The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options.

Description

The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options.

The study will require a sample size of 90 patients randomized in a 2:3 between the two arms. Arm 1 (standard radiation therapy to tumor location and surrounding area) and Arm 2 (targeted radiation therapy to tumor location).

Patients will be followed for a total of 5 years.

Details
Condition Head and Neck Cancer
Treatment Radiotherapy to all dissected areas, Omit radiation to pN0 neck
Clinical Study IdentifierNCT03997643
SponsorLawson Health Research Institute
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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