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

August 2, 2023 updated by: Lawson Health Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
  • Ireland
    • County Cork
      • Wilton, County Cork, Ireland
        • Recruiting
        • Cork University Hospital
        • Contact:
    • County Galway
      • Galway, County Galway, Ireland, H91 T861
        • Recruiting
        • University Hospital Galway, Newcastle Road
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Martin, MD
        • Sub-Investigator:
          • Sanjines Claudia, MD
    • Dublin
      • Rathgar, Dublin, Ireland
        • Recruiting
        • St. Luke's Radiation Oncology Network
        • Contact:
    • Leinster
      • Dublin, Leinster, Ireland, D09FT51
        • Recruiting
        • Beaumont St. Luke's Centre
        • Contact:
  • United Kingdom
      • Glasgow, United Kingdom, G12 OYN
  • United States
    • Florida
      • Miami, Florida, United States, 33143
        • Recruiting
        • Miami Cancer Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional failure in the pN0 hemi-neck (s)
Time Frame: Baseline to 5 years
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
Time Frame: Baseline up to 12 months
Assessed with the MD Anderson Dysphagia Inventory (MDADI) scale
Baseline up to 12 months
Swallowing Quality of life
Time Frame: Baseline up to 12 months
Assessed with the EORTC QLQ-C30 scale
Baseline up to 12 months
Swallowing Quality of life
Time Frame: Baseline up to 12 months
Assessed with the EORTC QLQ H&N 35 scale
Baseline up to 12 months
Health Status Quality of life
Time Frame: Baseline up to 12 months
Assessed with the EORTC EQ-5D-5L scale
Baseline up to 12 months
Overall survival
Time Frame: Baseline to 5 years
Defined as time from randomization to death from any cause
Baseline to 5 years
Disease free survival
Time Frame: Baseline to 5 years
Defined as the measure of time after treatment during which no sign of cancer is found
Baseline to 5 years
Local recurrence
Time Frame: 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.
Baseline to 5 years
Regional recurrence
Time Frame: Baseline to 5 years
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
Time Frame: 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.
Baseline to 5 years
Rate of salvage treatment (surgery +/- radiotherapy) in the pN0 neck and freedom from unsalvageable neck recurrence
Time Frame: Baseline 5 years
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
Time Frame: Randomization to 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
Time Frame: Baseline to 1 year
Measured by the Modified Barium Swallow Impairment (MBsimp) score
Baseline to 1 year
Swallowing function
Time Frame: Baseline to 1 year
Measured by the Dynamic Imaging Grade of Swallowing Toxicity score
Baseline to 1 year
Swallowing function
Time Frame: Baseline to 1 year
Measured by the Functional Oral Intake Score
Baseline to 1 year
Rate of toxicity
Time Frame: Baseline to 5 years
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
Time Frame: Baseline to 5 years
defined as time from randomization to failure in the cN0 neck
Baseline to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2019

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

June 24, 2019

First Posted (Actual)

June 25, 2019

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRESERVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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