SW-IMRT Versus ST-IMRT in the Treatment of Head and Neck Cancer

September 12, 2021 updated by: National Cancer Institute, Egypt

Swallowing Sparing IMRT (SW-IMRT) Versus Standard Parotid Sparing IMRT (ST-IMRT) in the Treatment of Head and Neck Cancer

To clinically validate whether SW-IMRT actually reduce the occurrence of swallowing dysfunction as compared to ST-IMRT.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients are randomly assigned to either ST-IMRT or SW-IMRT.

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • May Ashour

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: ST-IMRT
standard parotid sparing IMRT
Radiation: ST-IMRT SW-IMRT
EXPERIMENTAL: SW-IMRT
swallowing sparing IMRT
Radiation: ST-IMRT SW-IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective assessment of the swallowing function (dysphagia) at regular intervals
Time Frame: 6 months
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).
6 months
Objective assessment of the swallowing function (dysphagia) at regular intervals
Time Frame: 6 months
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 )
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local control
Time Frame: 6 months
Clinical examination and Imaging will be done at regular interval to detect local or nodal recurrence
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ACTUAL)

November 30, 2016

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (ACTUAL)

October 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 12, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD201001409.3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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