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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

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: Radiotherapy to all dissected areas Radiation: Omit radiation to pN0 neck Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2026

Arm Intervention/treatment
Active Comparator: Standard Radiotherapy
Radiotherapy to all dissected areas
Radiation: Radiotherapy to all dissected areas
Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas

Experimental: Radiotherapy to smaller treatment area
Omit radiation to pN0 neck
Radiation: Omit radiation to pN0 neck
post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Swallowing Quality of life [ Time Frame: Baseline up to 12 months ]
    Assessed with the MD Anderson Dysphagia Inventory (MDADI) scale

  2. Swallowing Quality of life [ Time Frame: Baseline up to 12 months ]
    Assessed with the EORTC QLQ-C30 scale

  3. Swallowing Quality of life [ Time Frame: Baseline up to 12 months ]
    Assessed with the EORTC QLQ H&N 35 scale

  4. Health Status Quality of life [ Time Frame: Baseline up to 12 months ]
    Assessed with the EORTC EQ-5D-5L scale

  5. Overall survival [ Time Frame: Baseline to 5 years ]
    Defined as time from randomization to death from any cause

  6. 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

  7. 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.

  8. 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

  9. 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.

  10. 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

  11. 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

  12. Swallowing function [ Time Frame: Baseline to 1 year ]
    Measured by the Modified Barium Swallow Impairment (MBsimp) score

  13. Swallowing function [ Time Frame: Baseline to 1 year ]
    Measured by the Dynamic Imaging Grade of Swallowing Toxicity score

  14. Swallowing function [ Time Frame: Baseline to 1 year ]
    Measured by the Functional Oral Intake Score

  15. Rate of toxicity [ Time Frame: Baseline to 5 years ]
    Assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4

  16. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997643


Locations
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Canada, Ontario
London Regional Cancer Program Not yet recruiting
London, Ontario, Canada, N6A 5W9
Contact: David Palma, MD    519-685-8500    David.Palma@lhsc.on.ca   
Contact: Susan Archer    519-685-8618    Susan.Archer@lhsc.on.ca   
Sponsors and Collaborators
Lawson Health Research Institute

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03997643     History of Changes
Other Study ID Numbers: PRESERVE
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lawson Health Research Institute:
Radiation Therapy
Oral Cavity Squamous Cell Carcinoma
Randomized Trial
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell