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

Primary Purpose

Head and Neck Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Radiotherapy to all dissected areas
Omit radiation to pN0 neck
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Radiation Therapy, Oral Cavity Squamous Cell Carcinoma, Randomized Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Miami Cancer InstituteRecruiting
  • London Regional Cancer ProgramRecruiting
  • CHUMRecruiting
  • Cork University HospitalRecruiting
  • University Hospital Galway, Newcastle RoadRecruiting
  • St. Luke's Radiation Oncology NetworkRecruiting
  • Beaumont St. Luke's CentreRecruiting
  • Beatson West of Scotland Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Radiotherapy

Radiotherapy to smaller treatment area

Arm Description

Radiotherapy to all dissected areas

Omit radiation to pN0 neck

Outcomes

Primary Outcome Measures

Regional failure in the pN0 hemi-neck (s)
Rate of relapse in the pN0 neck in Arm 2 compared to historical controls

Secondary Outcome Measures

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

Full Information

First Posted
June 14, 2019
Last Updated
August 2, 2023
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03997643
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2019 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Radiation Therapy, Oral Cavity Squamous Cell Carcinoma, Randomized Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Radiotherapy
Arm Type
Active Comparator
Arm Description
Radiotherapy to all dissected areas
Arm Title
Radiotherapy to smaller treatment area
Arm Type
Experimental
Arm Description
Omit radiation to pN0 neck
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy to all dissected areas
Intervention Description
Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas
Intervention Type
Radiation
Intervention Name(s)
Omit radiation to pN0 neck
Intervention Description
post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck
Primary Outcome Measure Information:
Title
Regional failure in the pN0 hemi-neck (s)
Description
Rate of relapse in the pN0 neck in Arm 2 compared to historical controls
Time Frame
Baseline to 5 years
Secondary Outcome Measure Information:
Title
Swallowing Quality of life
Description
Assessed with the MD Anderson Dysphagia Inventory (MDADI) scale
Time Frame
Baseline up to 12 months
Title
Swallowing Quality of life
Description
Assessed with the EORTC QLQ-C30 scale
Time Frame
Baseline up to 12 months
Title
Swallowing Quality of life
Description
Assessed with the EORTC QLQ H&N 35 scale
Time Frame
Baseline up to 12 months
Title
Health Status Quality of life
Description
Assessed with the EORTC EQ-5D-5L scale
Time Frame
Baseline up to 12 months
Title
Overall survival
Description
Defined as time from randomization to death from any cause
Time Frame
Baseline to 5 years
Title
Disease free survival
Description
Defined as the measure of time after treatment during which no sign of cancer is found
Time Frame
Baseline to 5 years
Title
Local recurrence
Description
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.
Time Frame
Baseline to 5 years
Title
Regional recurrence
Description
Defined as recurrence that occurs in the lymph nodes and tissue located in the vicinity of your original cancer
Time Frame
Baseline to 5 years
Title
Locoregional recurrence
Description
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.
Time Frame
Baseline to 5 years
Title
Rate of salvage treatment (surgery +/- radiotherapy) in the pN0 neck and freedom from unsalvageable neck recurrence
Description
Rate of salvage treatment (surgery +/- radiotherapy) in the pN0 neck and freedom from
Time Frame
Baseline 5 years
Title
Rate of feeding tub insertion and rate of feeding tube use at 1-year post randomization
Description
Rate of feeding tub insertion and rate of feeding tube use at 1-year post randomization
Time Frame
Randomization to 1 year post randomization
Title
Swallowing function
Description
Measured by the Modified Barium Swallow Impairment (MBsimp) score
Time Frame
Baseline to 1 year
Title
Swallowing function
Description
Measured by the Dynamic Imaging Grade of Swallowing Toxicity score
Time Frame
Baseline to 1 year
Title
Swallowing function
Description
Measured by the Functional Oral Intake Score
Time Frame
Baseline to 1 year
Title
Rate of toxicity
Description
Assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4
Time Frame
Baseline to 5 years
Title
Rate of failure in the clinically node negative neck
Description
defined as time from randomization to failure in the cN0 neck
Time Frame
Baseline to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noah Kalman, MD
Phone
786-596-2000
Email
NoahK@baptisthealth.net
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pencilla Lang, MD
Phone
519-685-8500
Email
Pencilla.Lang@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Laura Bailey
Phone
519-685-8618
Email
LauraD.Bailey@lhsc.on.ca
Facility Name
CHUM
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Houda Bahig, MD
Phone
5148908000
Email
houda.bahig.chum@ssss.gouv.qc.ca
Facility Name
Cork University Hospital
City
Wilton
State/Province
County Cork
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Rock, MD
Phone
1 353 86 8420854
Email
kathy.rock@hse.ie
Facility Name
University Hospital Galway, Newcastle Road
City
Galway
State/Province
County Galway
ZIP/Postal Code
H91 T861
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Stone
Phone
+353 91 54 8709
Email
emma.stone@hse.ie
First Name & Middle Initial & Last Name & Degree
Laura Nally
Phone
+353 91 54 8710
Email
laura.nally@hse.ie
First Name & Middle Initial & Last Name & Degree
Joseph Martin, MD
First Name & Middle Initial & Last Name & Degree
Sanjines Claudia, MD
Facility Name
St. Luke's Radiation Oncology Network
City
Rathgar
State/Province
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sinead Brennan, MD
Phone
353 1 406 5000
Email
sinead.brennan@slh.ie
Facility Name
Beaumont St. Luke's Centre
City
Dublin
State/Province
Leinster
ZIP/Postal Code
D09FT51
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sinead Brennan
Phone
353 1 406 5000
Email
sinead.brennan@slh.ie
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 OYN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Paterson, MD
Phone
0141 301 7066
Email
Claire.Paterson2@ggc.scot.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32795322
Citation
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.
Results Reference
derived

Learn more about this trial

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

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