locally advanced squamous cell carcinoma of head and neck. Malignant neoplasm of head, face and neck
Conditions
Interventions
Intervention 1: Intervention group: receiving hyperfractionated irradiation with low dose concurrent chemotherapy. Patients in this group treating by hyperfraction radiation therapy, with a total dose
Sponsors
Kerman University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Hasan Larizadeh
Kerman University of Medical Sciences
Outcome results
None listed