Clinical trial NCT03997643: Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
Official title: Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: Radiation Therapy
Oral Cavity Squamous Cell Carcinoma
Randomized Trial
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Regional failure in the pN0 hemi-neck (s)
timeFrame: Baseline to 5 years
Secondary outcomes:
measure: Swallowing Quality of life
timeFrame: Baseline up to 12 months
measure: Swallowing Quality of life
timeFrame: Baseline up to 12 months
measure: Swallowing Quality of life
timeFrame: Baseline up to 12 months
measure: Health Status Quality of life
timeFrame: Baseline up to 12 months
measure: Overall survival
timeFrame: Baseline to 5 years
measure: Disease free survival
timeFrame: Baseline to 5 years
measure: Local recurrence
timeFrame: Baseline to 5 years
measure: Regional recurrence
timeFrame: Baseline to 5 years
measure: Locoregional recurrence
timeFrame: Baseline to 5 years
measure: Rate of salvage treatment (surgery +/- radiotherapy) in the pN0 neck and freedom from unsalvageable neck recurrence
timeFrame: Baseline 5 years
measure: Rate of feeding tub insertion and rate of feeding tube use at 1-year post randomization
timeFrame: Randomization to 1 year post randomization
measure: Swallowing function
timeFrame: Baseline to 1 year
measure: Swallowing function
timeFrame: Baseline to 1 year
measure: Swallowing function
timeFrame: Baseline to 1 year
measure: Rate of toxicity
timeFrame: Baseline to 5 years
measure: Rate of failure in the clinically node negative neck
timeFrame: Baseline to 5 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Montréal
country: Canada
facility: CHUM
state: Quebec
city: Wilton
country: Ireland
facility: Cork University Hospital
state: County Cork
city: Galway
country: Ireland
facility: University Hospital Galway, Newcastle Road
state: County Galway
city: Rathgar
country: Ireland
facility: St. Luke's Radiation Oncology Network
state: Dublin
city: Dublin
country: Ireland
facility: Beaumont St. Luke's Centre
state: Leinster
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
Study officials:
References:
citation: Lang P, Contreras J, Kalman N, Paterson C, Bahig H, Billfalk-Kelly A, Brennan S, Rock K, Read N, Venkatesan V, Sathya J, Mendez LC, MacNeil SD, Nichols AC, Fung K, Mendez A, Winquist E, Kuruvilla S, Stewart P, Warner A, Mitchell S, Theurer JA, Palma DA. Preservation of swallowing in resected oral cavity squamous cell carcinoma: examining radiation volume effects (PRESERVE): study protocol for a randomized phase II trial. Radiat Oncol. 2020 Aug 14;15(1):196. doi: 10.1186/s13014-020-01636-x.