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Bladder Cancer clinical trials

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NCT ID: NCT01284205 Withdrawn - Bladder Cancer Clinical Trials

First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC

Start date: January 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.

NCT ID: NCT01276665 Completed - Bladder Cancer Clinical Trials

Effects of Noradrenaline Administration Combined With Restrictive Intraoperative Fluid Substitution on Perioperative Outcome in Patients Undergoing Radical Cystectomy

Start date: November 2009
Phase: N/A
Study type: Interventional

Perioperative fluid management in abdominal surgery is a subject of controversy and current standard fluid therapy is not evidence based. Compensating decreasing blood pressure by volume substitution is common praxis. Alternatively the fall in blood pressure due to vasodilatation can be corrected by applying vasoactive agents. A review of the data on the effect of "high volume" perioperative fluid therapy suggests that overhydration may have deleterious effects on cardiopulmonary function as well as on recovery of gastrointestinal motility, tissue oxygenation and wound healing. Restrictive fluid administration in fast-track surgery led to no differences in all-over recovery after colonic surgery. Based on our current knowledge, a low volume regimen combined with a noradrenaline perfusor may be of benefit during open radical cystectomy. It seems of interest and safe to use a noradrenaline perfusor combined with a low volume regimen during open radical cystectomy. The low volume regimen, as described in this study protocol, is well established at our institution, which has a large experience in cystectomy. The aim of this study is to compare intraoperative blood loss, quality of the surgical field, metabolic response, pain relief, fatigue score, gastrointestinal function, cardiovascular, pulmonary, infectious and surgical complications as well as cognitive function in two groups of patients undergoing radical cystectomy. The investigators expect a lower complication rate in the restrictive fluid regimen group and better surgical conditions. This could significantly affect short- and long-term outcome of patient undergoing major cancer surgery, have an impact on survival and financial consequences.

NCT ID: NCT01273987 Completed - Bladder Cancer Clinical Trials

Neobladder Posterior Wall Suspended With Round Ligament of Uterus

Start date: January 1, 2011
Phase: N/A
Study type: Interventional

Objective: to evaluate if the Neobladder posterior wall suspended with round ligament of uterus could improve neobladder empty after radical cystectomy in female patients with bladder cancer compared to present standard neobladder

NCT ID: NCT01259063 Completed - Bladder Cancer Clinical Trials

RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder

Start date: December 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test the safety of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to assess the right doses. Gemcitabine will be given at a fixed dose. Up to 3 dose levels of everolimus will be evaluated. The purpose of the phase II part is to test the combination of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to study the effects of these two drugs together. The investigators want to find out what effects, good and/or bad, this treatment has on the patient and the cancer.

NCT ID: NCT01240824 Completed - Bladder Cancer Clinical Trials

Study of BCG + Aminophylline Toxicity When Used in the Treatment of Bladder Cancer

BCG
Start date: July 2010
Phase: Phase 0
Study type: Interventional

The purpose of this study is to evaluate whether a new potential treatment for non invasive bladder cancer is safe and if it leads to side effects such as irregular heart rate, agitation, or burning with urination. Patients who have early stage bladder cancer and will be receiving BCG, a bladder cancer therapy as recommended by a doctor, will be asked to participate in a study where they are given the standard BCG followed by the experimental drug, aminophylline. Although we hope this medicine may one day prove to help bladder cancer patients, at the current time we do not know if it has any benefits at all. We have data in mice that suggest that aminophylline slows the growth of tumors when coupled with BCG.

NCT ID: NCT01236053 Completed - Breast Cancer Clinical Trials

Cancer in Patients With Gabapentin (GPRD)

Start date: June 2010
Phase: N/A
Study type: Observational

High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by spontaneous reports in AERS or in the published literature. In a published case-control screening study of the association of gabapentin with 55 cancers, the only cancer that met the screening criteria for possibly increased cancer risk with gabapentin exposure was renal (including renal pelvis) cancer. This association was judged to be likely due to or substantially accentuated by confounding by cigarette smoking, hypertension, and lifestyle (Cancer Causes Control 2009;20:1821-1835). The relationship between gabapentin exposure and pancreatic cancer and renal cancer is studied in NCT01138124, and supplemental analyses for these cancers are performed in the current study. The FDA recommended GSK also study the relationship between gabapentin and all-cancer sites, as well as cancer at the following specific sites: 1) stomach, 2) anus, anal canal, and anorectum, 3) lung and bronchus, 4) bones and joints, 5) breast, 6) penis, 7) urinary bladder, and 8) other nervous system. The primary objective of this study is to determine whether exposure to gabapentin is associated with an increased risk of developing all-cancer, and these specific cancers in the United Kingdom (UK) General Practice Research Database (GPRD). Each member of the UK population is registered with a General Practice, which centralizes the medical information not only from the general practitioners themselves but also from specialist referrals and hospital attendances. Over 487 General Practices contribute data to the GPRD. The study cohort from which cases and controls are drawn is all subjects in the GPRD 1993-2008. Gabapentin was approved in the UK in May 1993. Entry into the study cohort begins Jan 1, 1993 for all those who are registered in GPRD before that time, and at the time of registration if later than Jan 1, 1993. Subjects are excluded from the GPRD cohort if they have a cancer diagnosis or a history of cancer prior to the cohort entry date. Patients with a first diagnosis of the respective cancer 1995-2008 are risk set matched with up to 10 controls within the same General Practice for age at cohort entry (within two years), sex, and year of entry into the study cohort (within one year). For cases, the index date is the date of first diagnosis of the respective cancer. The index date for controls is set as the date at which the follow-up time from cohort entry is the same as the case. The index date is chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Cases and controls will be required to have at least 2 years of follow-up in the study cohort before their index date. Cases must have no history of any other cancer diagnosis prior to the index date. Controls are required to be free of cancer diagnosis in the database up to the control's index date. Data on gabapentin prescriptions are obtained for cases and controls from study cohort entry to the index date. Gabapentin exposure will be assessed as ever/never, number of prescriptions, cumulative dose, and cumulative duration, with a 2 year lag period incorporated to control for protopathic bias (gabapentin prescription for initial pain symptoms of undiagnosed cancer) and latency (time between cancer onset and specific GPRD cancer diagnosis). Crude and adjusted odds ratios and 95% confidence intervals (CI) will be produced from conditional logistic regression models, with additional analyses evaluating for dose-response. Covariates include indications for gabapentin use and risk factors for each cancer.

NCT ID: NCT01224665 Active, not recruiting - Bladder Cancer Clinical Trials

S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer

Start date: November 25, 2011
Phase: N/A
Study type: Interventional

RATIONALE: Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in patients with invasive bladder cancer. It is not yet known whether extended pelvic lymphadenectomy is more effective than standard pelvic lymphadenectomy during surgery. PURPOSE: This randomized phase II trial is studying standard pelvic lymphadenectomy to see how well it works compared to extended pelvic lymphadenectomy in treating patients undergoing surgery for invasive bladder cancer.

NCT ID: NCT01222676 Recruiting - Bladder Cancer Clinical Trials

Cisplatin, Gemcitabine Hydrochloride, and Sorafenib Tosylate in Treating Patients With Transitional Cell Cancer of the Bladder

Start date: October 2010
Phase: Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Giving cisplatin and gemcitabine hydrochloride together with sorafenib tosylate may kill more tumor cells. Giving them before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving cisplatin and gemcitabine hydrochloride together with sorafenib tosylate works in treating patients with node-negative transitional cell cancer of the bladder.

NCT ID: NCT01215266 Terminated - Bladder Cancer Clinical Trials

Sorafenib in Urothelium Cancer of Bladder

Start date: October 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the use of Sorafenib additionally to gemcitabine and cisplatin in bladder cancer.

NCT ID: NCT01215071 Completed - Bladder Cancer Clinical Trials

Eingeschränkte vs Ausgedehnte Lymphadenektomie LEA

Start date: February 2006
Phase: N/A
Study type: Interventional

This trial evaluates the therapeutic benefit of extended versus limited lymphadenectomy at the time of radical cystectomy in patients with bladder cancer.