RECRUITING

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

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Conditions

Head and Neck CancerRadiation TherapyOral Cavity Squamous Cell CarcinomaRandomized Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-09-06
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03997643

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing to provide informed consent
  2. * ECOG performance status 0-2
  3. * Histologically confirmed, resected oral cavity squamous cell carcinoma with at least ipsilateral selective neck disection
  4. * 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
  5. * Pathologically lympth node negative in at least one dissected hemi-neck with at least 10 nodes recovered in each pN0 hemi-neck
  1. * Serious medical comorbidities or other contraindications to radiotherapy
  2. * Prior history of head and neck cancer within 5 years
  3. * Any other active invasive malignancy, except non-melanotic skin cancers
  4. * Prior head and neck radiation at any time
  5. * Prior oncologic head and neck surgery in the oral cavity or neck
  6. * Metastatic disease
  7. * Locoregional disease recurrence identified following surgical resection but prior to the start of radiotherapy
  8. * Inability to attend full course of radio therapy or follow-up visits
  9. * Unable or unwilling to complete QoL questionnaires
  10. * Pregnant or lactating women

Contacts and Locations

Study Locations (Sites)

Miami Cancer Institute
Miami, Florida, 33143
United States

Collaborators and Investigators

Sponsor: Lawson Health Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-06
Study Completion Date2026-09

Study Record Updates

Study Start Date2019-09-06
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • Radiation Therapy
  • Oral Cavity Squamous Cell Carcinoma
  • Randomized Trial

Additional Relevant MeSH Terms

  • Head and Neck Cancer