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IRCT2015112225185N1 IRCT 2015-12-05 Ahvaz University Of Medical Sciences Complication assessment of chemotherapy with radiotherapy in head and neck tumors The comparison of acute toxicities and loading dose of drug in weekly and three - weekly Cisplatin delivered concomitant with radiotherapy in Squamous cell carcinoma of head and neck. 2015-02-20 anticipated 90 Complete https://irct.ir/trial/21096 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Condition 1: Head and neck tumor. Condition 2: Head and neck tumor. Condition 3: Head and neck tumor. Condition 4: Head and neck tumor. Condition 5: Head and neck tumor. Condition 6: Head and neck tumor. Condition 7: Head and neck tumor. Condition 8: Head and neck tumor. Condition 9: Head and neck tumor. Condition 10: Head and neck tumor. Condition 11: Head and neck tumor. Condition 12: Head and neck tumor. Intervention 1: In the first group IV Cisplatin will be administered with the dose of 40 mg/ m2 once weekly concurrently with radiotherapy. Intervention 2: In the second group IV Cisplatin will be administered three- weekly with the dose of 100 mg/m2 concurrently with radiotherapy.
public Dr Hojatolah Shahbazian
Radiotherap Ward,Golestan Hospital, Ahvaz, Khozestan
Ahvaz Iran (Islamic Republic of) +98 61 3374 3057 hjshahbazian@yahoo.com somaye.barihi@gmail.com Ahvaz, Golestan Hospital,Radiotherapy Ward scientific Dr Hojaolah Shahbazian
Radiotherapy Ward,Golestan Hospita, Ahvaz,Khozestan
Ahvaz Iran (Islamic Republic of) +98 61 3374 3057 hjshahbazian@yahoo.com somaye.barihi@ gmail.com Ahvaz, Golestan Hospital, Radiotherapy Ward Iran (Islamic Republic of) (Inclusion criteria: Pathologic report of Squamous.cell.carcinoma ; Age 18- 70 years ; ECOG performance status of 0-1; No distant metastasis; WBC equal to more than 4000; PLT equal to more than 100000; Hb equal to more than 10; Serum Cr less than 1.5 ; Serum aminotransferase less than twice of normal range.) (Exclusion criteria: Sever medical or psychiatric disorder; Patient who dose not have a good fallow up.) 75 years 23 years Both C00 C01 C03 C02 C04 C05 C06 C10 C11 C12 C13 C14 Malignant neoplasm of lip Malignant neoplasm of base of tongue Malignant neoplasm of gum Malignant neoplasm of other and unspecified parts of tongue Malignant neoplasm of floor of mouth Malignant neoplasm of palate Malignant neoplasm of other and unspecified parts of mouth Malignant neoplasm of oropharynx Malignant neoplasm of nasopharynx Malignant neoplasm of piriform sinus Malignant neoplasm of hypopharynx Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx Treatment - Drugs Treatment - Drugs In the first group IV Cisplatin will be administered with the dose of 40 mg/ m2 once weekly concurrently with radiotherapy In the second group IV Cisplatin will be administered three- weekly with the dose of 100 mg/m2 concurrently with radiotherapy Hematologic disorders. Timepoint: Befor start of treatment then weekly in first group and three weekly in second group. Method of measurement: CBC markers. Neutropenic fever. Timepoint: Befor start of treatment then weekly in first group and three weekly in second group. Method of measurement: CBC markers and oral temperature. Renal disorders. Timepoint: Befor start of treatment then weekly in first group and three weekly in second group. Method of measurement: Serum Cr. GI disorders. Timepoint: Befor start of treatment then weekly in first group and three weekly in second group. Method of measurement: Clinical presentation of acute and chronic nausea and vomiting /oral mucositis/more than twice of normal range of liver enzymes. Stopping the treatment. Timepoint: During treatment time. Method of measurement: With each complications. Hypersensitivity reaction. Timepoint: Befor start of treatment then weekly in first group and three weekly in second group. Method of measurement: Clinical presentation. Sensory neuropathy. Timepoint: Befor start of treatment then weekly in first group and three weekly in second group. Method of measurement: Clinical presentation of paresthesia in hands and feet. Accumulative dose. Timepoint: End of treatment. Method of measurement: Accumulation of all drug doses during treatment. Stage of disease. Timepoint: Start of treatment. Method of measurement: TNM system. Ahvaz University Of Medical Sciences Approved 2015-03-10 Ahvaz University Of Medical Sciences Golestan, Ahvaz, Khozestan Ahvaz Iran (Islamic Republic of)