Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
Purpose
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.
Condition
- Head and Neck Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Standard Radiotherapy |
Radiotherapy to all dissected areas |
|
|
Experimental Radiotherapy to smaller treatment area |
Omit radiation to pN0 neck |
|
Recruiting Locations
Miami, Florida 33143
More Details
- Status
- Recruiting
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study Contact
Detailed 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.