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IRCT20171204037739N1 IRCT 2018-03-18 Ahvaz University of Medical Sciences Levostatin eficacy and safety in treatment of squamous carcinoma of head and neck The impact of adding lovastatin to definitive chemoradiation therapy on response rate and acute treatment related toxicity in patients with squamus cell carcinoma of head and neck 2018-02-20 anticipated 60 Complete https://irct.ir/trial/29457 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with Random allocation software and then allocation concealment with central randomization will be done, Blinding description: All the patients that registered in trial and reaserchers, and analyzers and persons who will be assess the reasons will be blinded about who will be in case or control group just a physician who is care about patient will be know about that. 2 Condition 1: Squamous cell carcinoma of base of tongue. Condition 2: Squamous cell carcinoma of tongue. Condition 3: Squamous cell carcinoma of gum. Condition 4: Squamous cell carcinoma of floor of mouth. Condition 5: Squamous carcinoma of palate. Condition 6: Squamous cell carcinoma of other and unspecified parts of mouth. Condition 7: Squamous cell carcinoma of tonsil. Condition 8: Squamous cell carcinoma of oropharynx. Condition 9: Squamous cell carcinoma of nasopharynx. Condition 10: Squamous cell carcinoma of pyriformis sinus. Condition 11: Squamous carcinoma of hypopharynx. Condition 12: Squamous cell carcinoma of nsal cavity. Condition 13: Squamous cell carcinoma of paranasal sinus. Condition 14: Squamous cell carcinoma of larynx. Intervention 1: Intervention group: Tablet Levastatin 40mg twice a day during treatment+standard chemoradiotherapy. Intervention 2: Control group: standard chemoradiotherapy. 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 No more details are available.
public Pari Ghadamgahi
Golestan hospital, Farvardin St., Golestan Blvd.
Ahwaz Iran (Islamic Republic of) 33118_61357 0089 61 33337401 ghadamgahi.p@ajums.ac.ir Ahvaz University of Medical Sciences scientific Sasan Razmjoo
Golestan hospital., Farvardin St., Golestan Blvd
Ahwaz Iran (Islamic Republic of) 33118_61357 +98 61 3374 3057 razmju@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age more than 18years old Biopsy confirmed squamous cell carcinoma of head and neck 18 years no limit Both Surgical resection of head head and neck mass Use of Anti inflammatory drug or Asprine more than 3days in week Use of anti cuaglane drugs, fibrate, cyclosporine, OCP, Hypersensitivity to Levastatin Life expectancy shorter than 2years Received chemotherapy perior chemoradiotherapy Pregnancy C01 C02 C03 C04 C05 C06 C09 C10 C11 C12 C13 C30 C31 C32 Malignant neoplasm of base of tongue Malignant neoplasm of other and unspecified parts of tongue Malignant neoplasm of gum Malignant neoplasm of floor of mouth Malignant neoplasm of palate Malignant neoplasm of other and unspecified parts of mouth Malignant neoplasm of tonsil Malignant neoplasm of oropharynx Malignant neoplasm of nasopharynx Malignant neoplasm of pyriform sinus Malignant neoplasm of hypopharynx Malignant neoplasm of nasal cavity and middle ear Malignant neoplasm of accessory sinuses Malignant neoplasm of larynx Treatment - Drugs Treatment - Other Intervention group: Tablet Levastatin 40mg twice a day during treatment+standard chemoradiotherapy Control group: standard chemoradiotherapy Response rate. Timepoint: 8 weeks after treatment. Method of measurement: CT scan for response rate. Treatment related acute toxicity. Timepoint: Weekly during treatment. Method of measurement: Labratory test and physical examination. Ahvaz University of Medical Sciences Approved 2018-01-23 Ethics committee of Ahwaz Jondishapoor University of Medical Science Ahwaz Jondishapoor University of Medical Science, Golestan Blvd Ahwaz Khouzestan Iran (Islamic Republic of)