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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Radiation: Radiotherapy to all dissected areas
* Radiation: Omit radiation to pN0 neck


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Radiotherapy<br>Radiotherapy to all dissected areas | Radiation: Radiotherapy to all dissected areas<br>* Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas<br>|
| Experimental: Radiotherapy to smaller treatment area<br>Omit radiation to pN0 neck | Radiation: Omit radiation to pN0 neck<br>* post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional failure in the pN0 hemi-neck (s) | Rate of relapse in the pN0 neck in Arm 2 compared to historical controls | Baseline to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swallowing Quality of life | Assessed with the MD Anderson Dysphagia Inventory (MDADI) scale | Baseline up to 12 months | 
| Swallowing Quality of life | Assessed with the EORTC QLQ-C30 scale | Baseline up to 12 months | 
| Swallowing Quality of life | Assessed with the EORTC QLQ H&N 35 scale | Baseline up to 12 months | 
| Health Status Quality of life | Assessed with the EORTC EQ-5D-5L scale | Baseline up to 12 months | 
| Overall survival | Defined as time from randomization to death from any cause | Baseline to 5 years | 
| Disease free survival | Defined as the measure of time after treatment during which no sign of cancer is found | Baseline to 5 years | 
| Local recurrence | Defined as Cancer that has recurred at or near the same place as the primary tumor, usually after a period of time during which the cancer could not be detected. | Baseline to 5 years | 
| Regional recurrence | Defined as recurrence that occurs in the lymph nodes and tissue located in the vicinity of your original cancer | Baseline to 5 years | 
| Locoregional recurrence | Defined as the recurrence of cancer cells at the same site as the original tumor and/or the regional lymph nodes after a disease free period. | Baseline to 5 years | 
| Rate of salvage treatment (surgery +/- radiotherapy) in the pN0 neck and freedom from unsalvageable neck recurrence | Rate of salvage treatment (surgery +/- radiotherapy) in the pN0 neck and freedom from | Baseline 5 years | 
| Rate of feeding tub insertion and rate of feeding tube use at 1-year post randomization | Rate of feeding tub insertion and rate of feeding tube use at 1-year post randomization | Randomization to 1 year post randomization | 
| Swallowing function | Measured by the Modified Barium Swallow Impairment (MBsimp) score | Baseline to 1 year | 
| Swallowing function | Measured by the Dynamic Imaging Grade of Swallowing Toxicity score | Baseline to 1 year | 
| Swallowing function | Measured by the Functional Oral Intake Score | Baseline to 1 year | 
| Rate of toxicity | Assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 | Baseline to 5 years | 
| Rate of failure in the clinically node negative neck | defined as time from randomization to failure in the cN0 neck | Baseline to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation Therapy, Oral Cavity Squamous Cell Carcinoma, Randomized Trial