Back to resultsSW-IMRT Versus ST-IMRT in the Treatment of Head and Neck Cancer
Primary Purpose
Swallowing Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ST-IMRT SW-IMRT
Sponsored by
About this trial
This is an interventional treatment trial for Swallowing Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Patients with squamous cell carcinoma and requiring whole neck irradiation as a part of either definitive RT alone or in combination with chemotherapy or post-operative RT either alone or in combination with chemotherapy.
Exclusion Criteria:
- Previous radiotherapy to the head and neck region or prior malignancies, and/or distant metastases.
Sites / Locations
- May Ashour
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
ST-IMRT
SW-IMRT
Arm Description
standard parotid sparing IMRT
swallowing sparing IMRT
Outcomes
Primary Outcome Measures
Subjective assessment of the swallowing function (dysphagia) at regular intervals
Subjective assessment of swallowing function (dysphagia) will be scored on a scale of 0 (no dysphagia) to 4 (life threatening consequences; urgent intervention indicated) each follow-up visit on the basis of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4 (CTCAE 4).
Objective assessment of the swallowing function (dysphagia) at regular intervals
Objective assessment of swallowing will be made by videofluoroscopy and scored by Dynamic Imaging Grade of swallowing toxicity scale (DIGEST) and will be scored on a scale of 0 (no dysphagia) to 4 (life threatening )
Secondary Outcome Measures
local control
Clinical examination and Imaging will be done at regular interval to detect local or nodal recurrence
Full Information
NCT ID
NCT04597177
First Posted
September 3, 2020
Last Updated
September 12, 2021
Sponsor
National Cancer Institute, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT04597177
Brief Title
SW-IMRT Versus ST-IMRT in the Treatment of Head and Neck Cancer
Official Title
Swallowing Sparing IMRT (SW-IMRT) Versus Standard Parotid Sparing IMRT (ST-IMRT) in the Treatment of Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To clinically validate whether SW-IMRT actually reduce the occurrence of swallowing dysfunction as compared to ST-IMRT.
Detailed Description
Patients are randomly assigned to either ST-IMRT or SW-IMRT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swallowing Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ST-IMRT
Arm Type
Active Comparator
Arm Description
standard parotid sparing IMRT
Arm Title
SW-IMRT
Arm Type
Experimental
Arm Description
swallowing sparing IMRT
Intervention Type
Radiation
Intervention Name(s)
ST-IMRT SW-IMRT
Primary Outcome Measure Information:
Title
Subjective assessment of the swallowing function (dysphagia) at regular intervals
Description
Subjective assessment of swallowing function (dysphagia) will be scored on a scale of 0 (no dysphagia) to 4 (life threatening consequences; urgent intervention indicated) each follow-up visit on the basis of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4 (CTCAE 4).
Time Frame
6 months
Title
Objective assessment of the swallowing function (dysphagia) at regular intervals
Description
Objective assessment of swallowing will be made by videofluoroscopy and scored by Dynamic Imaging Grade of swallowing toxicity scale (DIGEST) and will be scored on a scale of 0 (no dysphagia) to 4 (life threatening )
Time Frame
6 months
Secondary Outcome Measure Information:
Title
local control
Description
Clinical examination and Imaging will be done at regular interval to detect local or nodal recurrence
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with squamous cell carcinoma and requiring whole neck irradiation as a part of either definitive RT alone or in combination with chemotherapy or post-operative RT either alone or in combination with chemotherapy.
Exclusion Criteria:
Previous radiotherapy to the head and neck region or prior malignancies, and/or distant metastases.
Facility Information:
Facility Name
May Ashour
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
SW-IMRT Versus ST-IMRT in the Treatment of Head and Neck Cancer
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