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

Sponsor

National Cancer Institute, Egypt (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04597177

Collaborator

(none)

146

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Swallowing Dysfunction	Radiation: ST-IMRT SW-IMRT	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

146 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Nov 30, 2016

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Subjective assessment of the swallowing function (dysphagia) at regular intervals [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).
Objective assessment of the swallowing function (dysphagia) at regular intervals [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 )

Secondary Outcome Measures

local control [6 months]
Clinical examination and Imaging will be done at regular interval to detect local or nodal recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	May Ashour	Cairo		Egypt

Sponsors and Collaborators

National Cancer Institute, Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Cancer Institute, Egypt

ClinicalTrials.gov Identifier:

NCT04597177

Other Study ID Numbers:

MD201001409.3

First Posted:

Oct 22, 2020

Last Update Posted:

Sep 20, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Head and Neck Neoplasms

Study Results

No Results Posted as of Sep 20, 2021