Hyperfractionated irradiation with and without concurrent chemotherapy in locally advanced head and neck cancer

Not Applicable

Conditions: locally advanced squamous cell carcinoma of head and neck.
Malignant neoplasm of head, face and neck
C76.0

Registration Number: IRCT20210404050835N1

Lead Sponsor: Kerman University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 112

Inclusion Criteria

The response of the patient's cancer tissue sample is of squamous cell carcinoma of the mucosa (non-skin).
The patient's cancer is locally advanced.
The age of patients is at least 18 years and at most 75 years.
The Karnofsky Performance Score of the patient is at least 60.
The patient should have no evidence of distant metastasis.
Not receiving previous radiation therapy and chemotherapy
Failure to perform previous surgery on the tumor
The patient is not pregnant

Exclusion Criteria

The patient has synchronous primary lesion.
Patient with squamous cell carcinoma of the scalp and neck.
Presence of underlying diseases such as diabetes and hypertension, renal failure, ischemic heart disease.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency of acute mucositis grade 3 and 4. Timepoint: 7, 14,21,28, 35, 42 and 49 days after intervention. Method of measurement: History and physical examination.;The frequency of neutropenia. Timepoint: 7, 14,21,28, 35, 42 and 49 days after intervention. Method of measurement: History and physical examination.;The frequency of neutropenic fever. Timepoint: 7, 14,21,28, 35, 42 and 49 days after intervention. Method of measurement: History and physical examination.;The frequency of nausea and vomiting. Timepoint: 7, 14,21,28, 35, 42 and 49 days after intervention. Method of measurement: History and physical examination.;The frequency of renal complications. Timepoint: Before intervention, 7, 14,21,28, 35, 42 and 49 days after intervention. Method of measurement: History and physical examination.;The frequency of heart complications. Timepoint: Before intervention, 7, 14,21,28, 35, 42 and 49 days after intervention. Method of measurement: History and physical examination and electrocardiogram.

Secondary Outcome Measures

Name	Time	Method
The disease-free survival rate. Timepoint: 18 months after intervention. Method of measurement: The telephone follow up.;The progression-free survival rate. Timepoint: 18 months after intervention. Method of measurement: The telephone follow up.;The overall survival rate. Timepoint: 18 months after intervention. Method of measurement: The telephone follow up.