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IRCT20210404050835N1 IRCT 2021-07-10 Kerman University of Medical Sciences Hyperfractionated irradiation with and without concurrent chemotherapy in locally advanced head and neck cancer The comparison of treatment outcomes between Hyperfractionated irradiation with and without concurrent chemotherapy in patients with locally advanced head and neck cancer 2021-07-23 anticipated 112 Complete https://irct.ir/trial/56313 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, patients randomly divided to two groups based on random number sequence. The random number sequence create by SAS statistical software and patients randomly allocated to intervention and control groups according to their entrance order. The random allocation will conceal by opaque, sealed envelopes, Blinding description: According to type of intervention, patients are not blind in this study, but data analyser and outcome assessor are blind. for data analysis, intervention and control groups are labeled with A and B and outcome assessor will follow up patients based on alphabetic list of names without name of groups. N/A locally advanced squamous cell carcinoma of head and neck. 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 of 8160 cGy in 68 fractions, with a dose of 120 cGy perfraction twice daily, with an interval of at least six hours between each fractions(according to the technique and dose that used in the phase 3 RTOG9003 trial) five days per week by Linear accelerator radiation therapy machine, with concurrent chemotherapy of low-dose Intravenous Carboplatin(equivalent to 1.5 AUC) one day weekly, for total treatment duration of 7 weeks. Intervention 2: Control group: receiving hyperfractionated irradiation. Patients in this group treating by hyperfraction radiation therapy, with a total dose of 8160 cGy in 68 fractions, with a dose of 120 cGy perfraction twice daily, with an interval of at least six hours between each fractions(according to the technique and dose that used in the phase 3 RTOG9003 trial) five days per week by Linear accelerator radiation therapy machine, fot total treatment duration of 7 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mohammad Hasan Larizadeh
Radioncology department, Afzalipour hospital, Imam highway
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3325 7235 mh.larizadeh@kmu.ac.ir Kerman University of Medical Sciences scientific mohamad hasan larizadeh
Radioncology department, Afzalipour hospital, Imam Khomeini highway
kerman Iran (Islamic Republic of) 7616913555 +98 34 3325 7236 mh.larizadeh@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) 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 18 years 75 years Both 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. C76.0 Malignant neoplasm of head, face and neck Treatment - Other Treatment - Other Intervention group: receiving hyperfractionated irradiation with low dose concurrent chemotherapy. Patients in this group treating by hyperfraction radiation therapy, with a total dose of 8160 cGy in 68 fractions, with a dose of 120 cGy perfraction twice daily, with an interval of at least six hours between each fractions(according to the technique and dose that used in the phase 3 RTOG9003 trial) five days per week by Linear accelerator radiation therapy machine, with concurrent chemotherapy of low-dose Intravenous Carboplatin(equivalent to 1.5 AUC) one day weekly, for total treatment duration of 7 weeks. Control group: receiving hyperfractionated irradiation. Patients in this group treating by hyperfraction radiation therapy, with a total dose of 8160 cGy in 68 fractions, with a dose of 120 cGy perfraction twice daily, with an interval of at least six hours between each fractions(according to the technique and dose that used in the phase 3 RTOG9003 trial) five days per week by Linear accelerator radiation therapy machine, fot total treatment duration of 7 weeks. 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. 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. Kerman University of Medical Sciences Approved 2021-02-15 Ethics committee of Kerman University of Medical Sciences Vice-challenger of Treatment, Jomhori Eslami blvd. Kerman Kerman Iran (Islamic Republic of)