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

Phase 2RecruitingNCT03997643

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's90 enrolled

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. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Miami Cancer Institute

Miami, Florida, United States

RECRUITING

London Regional Cancer Program

London, Ontario, Canada

RECRUITING

CHUM

Montreal, Quebec, Canada

RECRUITING

Cork University Hospital

Wilton, County Cork, Ireland

RECRUITING

University Hospital Galway, Newcastle Road

Galway, County Galway, Ireland

RECRUITING

St. Luke's Radiation Oncology Network

Rathgar, Dublin, Ireland

RECRUITING

Beaumont St. Luke's Centre

Dublin, Leinster, Ireland

RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Regional failure in the pN0 hemi-neck (s)

Rate of relapse in the pN0 neck in Arm 2 compared to historical controls

Time frame: Baseline to 5 years

Secondary Outcomes

Swallowing Quality of life

Assessed with the MD Anderson Dysphagia Inventory (MDADI) scale

Time frame: Baseline up to 12 months

Swallowing Quality of life

Assessed with the EORTC QLQ-C30 scale

Time frame: Baseline up to 12 months

Swallowing Quality of life

Assessed with the EORTC QLQ H\&N 35 scale

Time frame: Baseline up to 12 months

Health Status Quality of life

Assessed with the EORTC EQ-5D-5L scale

Time frame: Baseline up to 12 months

Overall survival

Defined as time from randomization to death from any cause

Time frame: Baseline to 5 years

Disease free survival

Defined as the measure of time after treatment during which no sign of cancer is found

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: Baseline 5 years

Rate of feeding tub insertion and rate of feeding tube use at 1-year post randomization

Time frame: Randomization to 1 year post randomization

Swallowing function

Measured by the Modified Barium Swallow Impairment (MBsimp) score

Time frame: Baseline to 1 year

Swallowing function

Measured by the Dynamic Imaging Grade of Swallowing Toxicity score

Time frame: Baseline to 1 year

Swallowing function

Measured by the Functional Oral Intake Score

Time frame: Baseline to 1 year

Rate of toxicity

Assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4

Time frame: Baseline to 5 years

Rate of failure in the clinically node negative neck

defined as time from randomization to failure in the cN0 neck

Time frame: Baseline to 5 years