Transitional Cell Carcinoma of bladder. Malignant neoplasm of bladder
Conditions
Interventions
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
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 consolid
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 comple
Sponsors
Vice-Chancellor for Research of Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to treatment. Timepoint: seven to eight weeks after initiation of induction treatment. Method of measurement: Cystoscopy biopsy and pathological review. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBaharak Keivan
Iran University of Medical Sciences
Outcome results
None listed