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IRCT2017040332913N2 IRCT 2017-06-25 Vice-Chancellor for Research of Iran University of Medical Sciences Response evaluation of muscle-invasive bladder cancer treated with radiotherapy and chemotherapy with Cisplatin or Gemcitabine Response Evaluation of Muscle-Invasive Bladder Cancer treated With Concomitant Chemoradiation By Either Irradiation Plus Weekly Cisplatin Or Irradiation Plus Low Dose Gemcitabine By Conventional Fractionated Radiotherapy 2017-06-22 anticipated 72 Complete https://irct.ir/trial/25532 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Two-arm randomized phase 2 trial. 2 Transitional Cell Carcinoma of bladder. Intervention 1: Group 1: Intravenous infusion of Gemcitabine (AQVIDA) 27 mg/m2 in 500 cc normal saline infused in 30 minutes on days 1, 4, 8, 11, 15, 18, 22, 25 of induction phase and days 1, 4, 8, 11, 15 of consolidation phase (if complete response to induction phase has achieved) with daily doses (2 Gy/Fr) of 3D- conformal conventional fractionated radiotherapy. Intervention 2: Group 2: Intravenous infusion of Cisplatin (EBEWE) 40 mg/m2 weekly in 30 minutes in 500 cc normal salineon on days 1, 8, 15, 22, in induction phase and days 1, 8, 15 in consolidation phase ( if complete response to induction phase is achieved), with daily doses (2Gy/Fr) of 3D- conformal conventional fractionated radiotherapy.
public Baharak Keivan
Hemmat Highway, Iran University of Medical Sciences, School of medicine
Tehran Iran (Islamic Republic of) +98 912 196 7353 dr_bkeyvan@yahoo.com Iran University of Medical Sciences scientific Dr Hoda Mahdavi
Firoozgar hospital, building No.3, Beh Afarin st., Karimkhan-e- Zand St., Vali e Asr Sq., Tehran
Tehran Iran (Islamic Republic of) +98 21 8214 1743 hoda.mahdavi@gmail.com Firoozgar Clinical Research Development Center (FCRDC) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Primary carcinoma of the bladder (Transitional Cell Cancer) with muscularis propria invasion diagnosed within 8 weeks of registration; clinical stage T2-T4a, Nx or N0, M0 without hydronephrosis; the patient can tolerate systemic chemotherapy combined with pelvic radiotherapy and a radical cystectomy by joint agreement of the Urologist and Oncologist; The following laboratory tests that has been done within 4 weeks prior to registration on this study is as following: WBC greater than or equal to 4000, ANC greater than or equal to 1800, Hemoglobin greater than or equal to 10.0, Platelets greater than or equal to 100,000, Creatinine clearance greater than or equal to 60ml/min, Serum creatinine of 1.5 or less, If no, the creatinine clearance is greater than 60 ml/min and serum creatinine is no more than 1.8 Serum bilirubin of less than or equal to 2.0 mg%; No evidence of distant metastases, The patient has not received prior pelvic radiation therapy or chemotherapy, nor had cancers other than non-melanoma skin cancer and early stage cancer of prostate or cervix; the patient has none of any of the severe, active co-morbidities defined as following: Unstable angina and/or congestive heart failure, requiring hospitalization within the last 6 months, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; acquired immune deficiency syndrome (AIDS) based upon current CDC definition; The patient has no known severe sensitivity reactions to the drugs used in the trial. 18 years no limit Both C67 Malignant neoplasm of bladder Treatment - Drugs Treatment - Drugs Group 1: Intravenous infusion of Gemcitabine (AQVIDA) 27 mg/m2 in 500 cc normal saline infused in 30 minutes on days 1, 4, 8, 11, 15, 18, 22, 25 of induction phase and days 1, 4, 8, 11, 15 of consolidation phase (if complete response to induction phase has achieved) with daily doses (2 Gy/Fr) of 3D- conformal conventional fractionated radiotherapy. Group 2: Intravenous infusion of Cisplatin (EBEWE) 40 mg/m2 weekly in 30 minutes in 500 cc normal salineon on days 1, 8, 15, 22, in induction phase and days 1, 8, 15 in consolidation phase ( if complete response to induction phase is achieved), with daily doses (2Gy/Fr) of 3D- conformal conventional fractionated radiotherapy. Response to treatment. Timepoint: seven to eight weeks after initiation of induction treatment. Method of measurement: Cystoscopy biopsy and pathological review. Disease Free Survival. Timepoint: Every 3 months for 2 years. Method of measurement: Follow-up with history, physical examination, scans and urine and blood tests. 95-04-143-29832 Iran University of Medical Sciences Research management system Vice-Chancellor for Research of Iran University of Medical Sciences Approved 2017-03-08 Ethics committee of Iran University of Medical Sciences Hemmat Highway Tehran Iran (Islamic Republic of)