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

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.

Conditions

Head and Neck Cancer

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Study Overview

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Study Details

Study overview

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.

Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects: A Randomized Trial

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

Condition
Head and Neck Cancer
Intervention / Treatment

-

Contacts and Locations

Miami

Miami Cancer Institute, Miami, Florida, United States, 33143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Lawson Health Research Institute,

Study Record Dates

2026-09