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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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