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

Last updated: August 2, 2023
Sponsor: Lawson Health Research Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Head And Neck Cancer

Carcinoma

Human Papilloma Virus (Hpv)

Treatment

Omit radiation to pN0 neck

Radiotherapy to all dissected areas

Clinical Study ID

NCT03997643
PRESERVE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willing to provide informed consent
  • ECOG performance status 0-2
  • Histologically confirmed, resected oral cavity squamous cell carcinoma with at leastipsilateral 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, andPORT 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

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 tothe 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

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Omit radiation to pN0 neck
Phase: 2
Study Start date:
September 06, 2019
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • London Regional Cancer Program

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • CHUM

    Montréal, Quebec H2X 0A9
    Canada

    Active - Recruiting

  • Cork University Hospital

    Wilton, County Cork
    Ireland

    Active - Recruiting

  • University Hospital Galway, Newcastle Road

    Galway, County Galway H91 T861
    Ireland

    Active - Recruiting

  • St. Luke's Radiation Oncology Network

    Rathgar, Dublin
    Ireland

    Active - Recruiting

  • Beaumont St. Luke's Centre

    Dublin, Leinster D09FT51
    Ireland

    Active - Recruiting

  • Cork University Hospital

    Wilton, Cork,
    Ireland

    Site Not Available

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 OYN
    United Kingdom

    Active - Recruiting

  • Miami Cancer Institute

    Miami, Florida 33143
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.