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

N/AUnknownNCT04597177

National Cancer Institute, Egypt146 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

146

Conditions

Swallowing Dysfunction

Interventions

ST-IMRT SW-IMRTRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

May Ashour

Cairo, Egypt

Outcomes

Primary Outcomes

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).

Time frame: 6 months

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 )

Time frame: 6 months

Secondary Outcomes

local control

Clinical examination and Imaging will be done at regular interval to detect local or nodal recurrence

Time frame: 6 months

Data from ClinicalTrials.gov

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