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

Not Applicable

• Conditions: Swallowing Dysfunction
• Interventions: Radiation: ST-IMRT SW-IMRT

• Registration Number: NCT04597177
• Lead Sponsor: National Cancer Institute, Egypt

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.

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2016-11-30
• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-12
• Last Update Posted: 2021-09-20
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 146

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SW-IMRT	ST-IMRT SW-IMRT	swallowing sparing IMRT
ST-IMRT	ST-IMRT SW-IMRT	standard parotid sparing IMRT

Primary Outcome Measures

Name	Time	Method
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 )
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).

Secondary Outcome Measures

Name	Time	Method
local control	6 months	Clinical examination and Imaging will be done at regular interval to detect local or nodal recurrence

Trial Locations

Locations (1)

May Ashour; 🇪🇬 Cairo, Egypt