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

Part of paid clinical trials in Miami, Florida.

Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study ID
NCT03997643
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiotherapy to all dissected areas — RADIATION
    Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas
  • Omit radiation to pN0 neck — RADIATION
    post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck

Study Details

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.

Key Dates

Start date
Sep 6, 2019
Status verified
Aug 2023
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Radiotherapy
    Radiotherapy to all dissected areas
  • Experimental: Radiotherapy to smaller treatment area
    Omit radiation to pN0 neck

Primary Outcome Measure

Regional failure in the pN0 hemi-neck (s) [ Time Frame: Baseline to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Miami Cancer InstituteMiamiFlorida33143
Noah Kalman, MD
[email protected]
786-596-2000

Find similar trials in Miami, FL

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Miami Cancer Institute· Miami, FL

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