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Head and Neck CancerPhase 2NCT03997643

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

A Phase 2 study testing Radiotherapy to all dissected areas and Omit radiation to pN0 neck in people with Head and Neck Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 8 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Radiotherapy to all dissected areas and Omit radiation to pN0 neck
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
8 sitesin 4 countries
Study dates
6 Sep 2019to Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

8 sites in 4 countries.

8 sites in 4 countries

Ireland4 sites

  • Beaumont St. Luke's Centre

    Dublin, Leinster, D09FT51

  • University Hospital Galway, Newcastle Road

    Galway, County Galway, H91 T861

  • St. Luke's Radiation Oncology Network

    Rathgar, Dublin

  • Cork University Hospital

    Wilton, County Cork

Other trials in Ireland

Canada2 sites

  • London Regional Cancer Program

    London, Ontario, N6A 5W9

  • CHUM

    Montreal, Quebec, H2X 0A9

Other trials in Canada

United States1 site

  • Miami Cancer Institute

    Miami, Florida, 33143

Other trials in United States

United Kingdom1 site

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 OYN

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
Radiotherapy to all dissected areas, Omit radiation to pN0 neck
Keywords
Radiation Therapy, Oral Cavity Squamous Cell Carcinoma, Randomized Trial
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiotherapy to all dissected areasRadiation

    Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas

  • Omit radiation to pN0 neckRadiation

    post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck

Study groups in NCT03997643
Study groupRoleWhat they receive
Standard RadiotherapyActive comparatorRadiotherapy to all dissected areas
Receives: Radiation: Radiotherapy to all dissected areas
Radiotherapy to smaller treatment areaExperimentalOmit radiation to pN0 neck
Receives: Radiation: Omit radiation to pN0 neck

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Regional failure in the pN0 hemi-neck (s)

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

    Measured: Baseline to 5 years

Secondary outcomes (16)

  1. Swallowing Quality of life

    Assessed with the MD Anderson Dysphagia Inventory (MDADI) scale

    Measured: Baseline up to 12 months

  2. Swallowing Quality of life

    Assessed with the EORTC QLQ-C30 scale

    Measured: Baseline up to 12 months

  3. Swallowing Quality of life

    Assessed with the EORTC QLQ H\&N 35 scale

    Measured: Baseline up to 12 months

  4. Health Status Quality of life

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

    Measured: Baseline up to 12 months

  5. Overall survival

    Defined as time from randomization to death from any cause

    Measured: Baseline to 5 years

  6. Disease free survival

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

    Measured: Baseline to 5 years

  7. 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.

    Measured: Baseline to 5 years

  8. Regional recurrence

    Defined as recurrence that occurs in the lymph nodes and tissue located in the vicinity of your original cancer

    Measured: Baseline to 5 years

  9. 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.

    Measured: Baseline to 5 years

  10. 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

    Measured: Baseline 5 years

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

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

    Measured: Randomization to 1 year post randomization

  12. Swallowing function

    Measured by the Modified Barium Swallow Impairment (MBsimp) score

    Measured: Baseline to 1 year

  13. Swallowing function

    Measured by the Dynamic Imaging Grade of Swallowing Toxicity score

    Measured: Baseline to 1 year

  14. Swallowing function

    Measured by the Functional Oral Intake Score

    Measured: Baseline to 1 year

  15. Rate of toxicity

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

    Measured: Baseline to 5 years

  16. Rate of failure in the clinically node negative neck

    defined as time from randomization to failure in the cN0 neck

    Measured: Baseline to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2019
  2. Study start6 Sep 2019
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03997643
Sponsor's protocol ID
PRESERVE
Status last verified
Sep 2026
First submitted
14 Jun 2019
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Evans M, Bonomo P, Chan PC, Chua MLK, Eriksen JG, Hunter K, Jones TM, Laskar SG, Maroldi R, O'Sullivan B, Paterson C, Tagliaferri L, Tribius S, Yom SS, Gregoire V. Post-operative radiotherapy for oral cavity squamous cell carcinoma: Review of the data guiding the selection and the delineation of post-operative target volumes. Radiother Oncol. 2025 Jun;207:110880. doi: 10.1016/j.radonc.2025.110880. Epub 2025 Apr 5.

    PubMed 40194704

  • 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.

    PubMed 32795322

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotherapy to all dissected areas and Omit radiation to pN0 neck in people with Head and Neck Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 8 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Ireland, Canada, United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Regional failure in the pN0 hemi-neck (s) (time frame: Baseline to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03997643, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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