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

Phase 2

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Radiation: Omit radiation to pN0 neck; Radiation: Radiotherapy to all dissected areas

• Registration Number: NCT03997643
• Lead Sponsor: Lawson Health Research Institute

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.

Study Timeline

• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-25
• Study Start: 2019-09-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-02
• Last Update Posted: 2023-08-03
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy to smaller treatment area	Omit radiation to pN0 neck	Omit radiation to pN0 neck
Standard Radiotherapy	Radiotherapy to all dissected areas	Radiotherapy to all dissected areas

Primary Outcome Measures

Name	Time	Method
Regional failure in the pN0 hemi-neck (s)	Baseline to 5 years	Rate of relapse in the pN0 neck in Arm 2 compared to historical controls

Secondary Outcome Measures

Name	Time	Method
Swallowing Quality of life	Baseline up to 12 months	Assessed with the EORTC QLQ H\&N 35 scale
Locoregional recurrence	Baseline to 5 years	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.
Local recurrence	Baseline to 5 years	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.
Regional recurrence	Baseline to 5 years	Defined as recurrence that occurs in the lymph nodes and tissue located in the vicinity of your original cancer
Rate of salvage treatment (surgery +/- radiotherapy) in the pN0 neck and freedom from unsalvageable neck recurrence	Baseline 5 years	Rate of salvage treatment (surgery +/- radiotherapy) in the pN0 neck and freedom from
Rate of failure in the clinically node negative neck	Baseline to 5 years	defined as time from randomization to failure in the cN0 neck
Rate of feeding tub insertion and rate of feeding tube use at 1-year post randomization	Randomization to 1 year post randomization	Rate of feeding tub insertion and rate of feeding tube use at 1-year post randomization
Rate of toxicity	Baseline to 5 years	Assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4
Health Status Quality of life	Baseline up to 12 months	Assessed with the EORTC EQ-5D-5L scale
Overall survival	Baseline to 5 years	Defined as time from randomization to death from any cause
Disease free survival	Baseline to 5 years	Defined as the measure of time after treatment during which no sign of cancer is found
Swallowing function	Baseline to 1 year	Measured by the Functional Oral Intake Score

Trial Locations

Locations (8)

Beatson West of Scotland Cancer Centre; 🇬🇧 Glasgow, United Kingdom

Beaumont St. Luke's Centre; 🇮🇪 Dublin, Leinster, Ireland

Cork University Hospital; 🇮🇪 Wilton, County Cork, Ireland

St. Luke's Radiation Oncology Network; 🇮🇪 Rathgar, Dublin, Ireland

Miami Cancer Institute; 🇺🇸 Miami, Florida, United States

CHUM; 🇨🇦 Montréal, Quebec, Canada

University Hospital Galway, Newcastle Road; 🇮🇪 Galway, County Galway, Ireland

London Regional Cancer Program; 🇨🇦 London, Ontario, Canada