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Active, not recruiting Phase 2

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

NCT03997643 · tracked via the Priya Life Science Ireland tracker
Phase
Phase 2
Started
2019-09-06
Last updated
2026-10-05

Condition(s) studied

Head and Neck Cancer

Investigational drug(s) / intervention(s)

Radiotherapy to all dissected areasOmit radiation to pN0 neck

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

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

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (8)

FacilityCityRegionStatus
Miami Cancer Institute Miami Florida
London Regional Cancer Program London Ontario
CHUM Montreal Quebec
Cork University Hospital Wilton County Cork
University Hospital Galway, Newcastle Road Galway County Galway
St. Luke's Radiation Oncology Network Rathgar Dublin
Beaumont St. Luke's Centre Dublin Leinster
Beatson West of Scotland Cancer Centre Glasgow United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03997643 on ClinicalTrials.gov ↗ ← All trials in Ireland