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

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ClinicalTrials.gov Identifier: NCT03997643
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date September 5, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date September 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
Regional failure in the pN0 hemi-neck (s) [ Time Frame: Baseline to 5 years ]
Rate of relapse in the pN0 neck in Arm 2 compared to historical controls
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03997643 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Swallowing Quality of life [ Time Frame: Baseline up to 12 months ]
    Assessed with the MD Anderson Dysphagia Inventory (MDADI) scale
  • Swallowing Quality of life [ Time Frame: Baseline up to 12 months ]
    Assessed with the EORTC QLQ-C30 scale
  • Swallowing Quality of life [ Time Frame: Baseline up to 12 months ]
    Assessed with the EORTC QLQ H&N 35 scale
  • Health Status Quality of life [ Time Frame: Baseline up to 12 months ]
    Assessed with the EORTC EQ-5D-5L scale
  • Overall survival [ Time Frame: Baseline to 5 years ]
    Defined as time from randomization to death from any cause
  • Disease free survival [ Time Frame: Baseline to 5 years ]
    Defined as the measure of time after treatment during which no sign of cancer is found
  • Local recurrence [ Time Frame: Baseline to 5 years ]
    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 [ Time Frame: Baseline to 5 years ]
    Defined as recurrence that occurs in the lymph nodes and tissue located in the vicinity of your original cancer
  • Locoregional recurrence [ Time Frame: Baseline to 5 years ]
    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 [ Time Frame: Baseline 5 years ]
    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 [ Time Frame: Randomization to 1 year post randomization ]
    Rate of feeding tub insertion and rate of feeding tube use at 1-year post randomization
  • Swallowing function [ Time Frame: Baseline to 1 year ]
    Measured by the Modified Barium Swallow Impairment (MBsimp) score
  • Swallowing function [ Time Frame: Baseline to 1 year ]
    Measured by the Dynamic Imaging Grade of Swallowing Toxicity score
  • Swallowing function [ Time Frame: Baseline to 1 year ]
    Measured by the Functional Oral Intake Score
  • Rate of toxicity [ Time Frame: Baseline to 5 years ]
    Assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4
  • Rate of failure in the clinically node negative neck [ Time Frame: Baseline to 5 years ]
    defined as time from randomization to failure in the cN0 neck
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
Official Title  ICMJE Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Standard Radiotherapy
    Radiotherapy to all dissected areas
    Intervention: Radiation: Radiotherapy to all dissected areas
  • Experimental: Radiotherapy to smaller treatment area
    Omit radiation to pN0 neck
    Intervention: Radiation: Omit radiation to pN0 neck
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2026
Estimated Primary Completion Date September 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03997643
Other Study ID Numbers  ICMJE PRESERVE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lawson Health Research Institute
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP