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

Official title

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

Overview

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.

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.

Interventions

• Radiation Radiotherapy to all dissected areas
  Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas
• Radiation Omit radiation to pN0 neck
  post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck

Primary outcome measures

• Regional failure in the pN0 hemi-neck (s) [Time frame: Baseline to 5 years]

Secondary outcome measures (12)

• Swallowing Quality of life [Time frame: Baseline up to 12 months]
• Swallowing Quality of life [Time frame: Baseline up to 12 months]
• Swallowing Quality of life [Time frame: Baseline up to 12 months]
• Health Status Quality of life [Time frame: Baseline up to 12 months]
• Overall survival [Time frame: Baseline to 5 years]
• Disease free survival [Time frame: Baseline to 5 years]
• Local recurrence [Time frame: Baseline to 5 years]
• Regional recurrence [Time frame: Baseline to 5 years]
• Locoregional recurrence [Time frame: 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 feeding tub insertion and rate of feeding tube use at 1-year post randomization [Time frame: Randomization to 1 year post randomization]
• Swallowing function [Time frame: Baseline to 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Ireland · 4 centers

• Cork University Hospital — Wilton
• University Hospital Galway, Newcastle Road — Galway
• St. Luke's Radiation Oncology Network — Rathgar
• Beaumont St. Luke's Centre — Dublin

Canada · 2 centers

• London Regional Cancer Program — London
• CHUM — Montreal

United States · 1 center

• Miami Cancer Institute — Miami

United Kingdom · 1 center

• Beatson West of Scotland Cancer Centre — Glasgow

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. PMID 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 ra PMID 32795322

Identifiers

NCT: NCT03997643 · PRESERVE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗