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

NCT03997643 | Recruiting Phase 2 DMC

• 1 other identifier: PRESERVE
• Study Type: interventional
• Target: 90
• Locations: 4 countries
• Sites: 8

Brief 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.

Conditions

Head and Neck Cancer

Keywords

Radiation Therapy; Oral Cavity Squamous Cell Carcinoma; Randomized Trial

Outcome Measures

Primary Outcomes (1)

• Regional failure in the pN0 hemi-neck (s)

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

  Baseline to 5 years

Secondary Outcomes (16)

• Swallowing Quality of life

  Baseline up to 12 months

• Swallowing Quality of life

  Baseline up to 12 months

• Swallowing Quality of life

  Baseline up to 12 months

• Health Status Quality of life

  Baseline up to 12 months

• Overall survival

  Baseline to 5 years

Study Arms (2)

Standard Radiotherapy

ACTIVE COMPARATOR

Radiotherapy to all dissected areas

Radiation: Radiotherapy to all dissected areas

Radiotherapy to smaller treatment area

EXPERIMENTAL

Omit radiation to pN0 neck

Radiation: Omit radiation to pN0 neck

Interventions

Radiotherapy to all dissected areas RADIATION

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

Standard Radiotherapy

Omit radiation to pN0 neck RADIATION

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

Radiotherapy to smaller treatment area

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (8)

Miami Cancer Institute

Miami, Florida, 33143, United States

RECRUITING

London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

RECRUITING

CHUM

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

Cork University Hospital

Wilton, County Cork, Ireland

RECRUITING

University Hospital Galway, Newcastle Road

Galway, County Galway, H91 T861, Ireland

RECRUITING

St. Luke's Radiation Oncology Network

Rathgar, Dublin, Ireland

RECRUITING

Beaumont St. Luke's Centre

Dublin, Leinster, D09FT51, Ireland

RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, G12 OYN, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 32795322 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 25, 2019
• Study Start: September 6, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

IE (4); GB (1); US (1); CA (2)