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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03997643
• Other study ID #: PRESERVE
• Status: Recruiting
• Phase: Phase 2
• Start date: September 6, 2019
• Est. completion date: September 2026

Study information

• Verified date: August 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 evidence to guide the selection of treatment options.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
Canada	London Regional Cancer Program	London	Ontario
Canada	CHUM	Montréal	Quebec
Ireland	Beaumont St. Luke's Centre	Dublin	Leinster
Ireland	University Hospital Galway, Newcastle Road	Galway	County Galway
Ireland	St. Luke's Radiation Oncology Network	Rathgar	Dublin
Ireland	Cork University Hospital	Wilton	County Cork
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United States	Miami Cancer Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Countries where clinical trial is conducted

United States,  Canada,  Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Swallowing Quality of life	Assessed with the MD Anderson Dysphagia Inventory (MDADI) scale	Baseline up to 12 months
Secondary	Swallowing Quality of life	Assessed with the EORTC QLQ-C30 scale	Baseline up to 12 months
Secondary	Swallowing Quality of life	Assessed with the EORTC QLQ H&N 35 scale	Baseline up to 12 months
Secondary	Health Status Quality of life	Assessed with the EORTC EQ-5D-5L scale	Baseline up to 12 months
Secondary	Overall survival	Defined as time from randomization to death from any cause	Baseline to 5 years
Secondary	Disease free survival	Defined as the measure of time after treatment during which no sign of cancer is found	Baseline to 5 years
Secondary	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.	Baseline to 5 years
Secondary	Regional recurrence	Defined as recurrence that occurs in the lymph nodes and tissue located in the vicinity of your original cancer	Baseline to 5 years
Secondary	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.	Baseline to 5 years
Secondary	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	Baseline 5 years
Secondary	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	Randomization to 1 year post randomization
Secondary	Swallowing function	Measured by the Modified Barium Swallow Impairment (MBsimp) score	Baseline to 1 year
Secondary	Swallowing function	Measured by the Dynamic Imaging Grade of Swallowing Toxicity score	Baseline to 1 year
Secondary	Swallowing function	Measured by the Functional Oral Intake Score	Baseline to 1 year
Secondary	Rate of toxicity	Assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4	Baseline to 5 years
Secondary	Rate of failure in the clinically node negative neck	defined as time from randomization to failure in the cN0 neck	Baseline to 5 years