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Bladder Cancer clinical trials

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NCT ID: NCT01812369 Active, not recruiting - Bladder Cancer Clinical Trials

Perioperative Chemotherapy for Patients With Locally Advanced Bladder Cancer

VESPER
Start date: February 2013
Phase: Phase 3
Study type: Interventional

Radical cystectomy remains the gold standard treatment for invasive non metastatic transitional cell cancer (TCC) of the bladder. In contemporary series, specific survival rates are about 60 to 65% at 5 years, decreasing for locally advanced disease to 45-50% in patients with nonorgan-confined lymph-node negative tumours and to 30-35% in patients with lymph node positive tumours. Perioperative chemotherapy (adjuvant ou neoadjuvant) has been developed in order to improve these results. Thanks to randomized trials and meta-analysis, it can be concluded that perioperative chemotherapy increases overall survival with an absolute benefit of 5%, equating to a survival rate of 50% at 5 years for nonorgan-confined tumours. However, the chemotherapy administration time and the optimal chemotherapy regimen to be delivered are not yet determined. Meta-analyses have shown that the benefit is only observed for chemotherapy regimens including cisplatin. In daily management 4 to 6 cycles of gemcitabine and cisplatin are delivered since this combination has been shown to yield a similar efficacy with a better tolerance as compared to the MVAC regimen (methotrexate, vinblastine, doxorubicin and cisplatin) in the metastatic setting. As HD-MVAC has been shown to be associated with higher response rates than MVAC in bladder metastatic disease, also a better efficacy of HD-MVAC can be suspected in the perioperative setting. Investigators therefore designed a randomized phase III study to compare the efficacy of GC and HD-MVAC in term of progression-free survival in patients for whom chemotherapy has been decided, before or after radical cystectomy. Secondary endpoints include overall survival, side effects, response rate in the neoadjuvant setting and ancillary studies focusing on gemcitabine and cisplatin sensitivity. The total number of patients projected is 500. The number of patients is based on the median progression-free survival rate of 50% at 3 years observed in patients treated with GC (standard arm A) in the perioperative setting. An absolute improvement of 10% (HR=0.74) is expected with HD-MVAC (experimental arm B) with a=0.05 and b=0.20. An interim analysis is planned after the occurrence of 174 events. With an estimated uniform accrual rate of 140 patients per year for 3.5 years and exponential survival, the final analysis is expected to occur 8 years after the start of the trial.

NCT ID: NCT01810757 Active, not recruiting - Bladder Cancer Clinical Trials

Study of Weekly Radiotherapy for Bladder Cancer

HYBRID
Start date: April 2014
Phase: N/A
Study type: Interventional

Background Localised muscle invasive bladder cancer (MIBC) is life-threatening and can cause significant symptoms. Around 50% of patients with MIBC who are referred for radiotherapy are unfit for standard radical treatment (surgery or daily radiotherapy with chemotherapy), but would have a normal life expectancy if their cancer were adequately controlled. Retrospective studies suggest that radiotherapy which is given weekly using fewer fractions and higher doses (hypofractionated), may be an alternative where daily radiotherapy is not an option. Radiotherapy treatment is planned based on information from a CT scan which shows the position and shape of the bladder. This plan needs to take into account the fact that the bladder's shape and position can change, depending on how full it is and because of where it is in relation to the bowel. A safety margin is therefore added around the bladder on the planned treatment, to reduce the risk of missing any of the bladder with the radiotherapy. It is now possible to take scans of the bladder's position before each treatment and adjust the position of the treatment plan accordingly to ensure the bladder is fully covered by it. In this study we are also looking at whether it is possible to design a series of treatment plans with different size safety margins and then choose one that fits best for each particular day. This is called 'adaptive radiotherapy'. This technique may enable accurate treatment delivery using smaller safety margins and this might help to reduce side effects. Aims In patients with MIBC not suitable for cystectomy or daily radiotherapy we aim to assess: 1. whether treatment using adaptive planning can be successfully delivered at multiple sites across the UK and results in acceptable levels of toxicity 2. the local tumour control rate achieved by hypofractionated weekly radiotherapy 3. the requirement to treat with adaptive planning. How results will be used Results will provide robust evidence for use of hypofractionated radiotherapy and assess whether this is a plausible and worthwhile treatment in this patient population. The randomised element of the trial will support the implementation of image-guided adaptive radiotherapy for bladder cancer in the UK. HYBRID will provide evidence on the benefits or otherwise of this methodology and inform the development of further trials in this and other patient groups.

NCT ID: NCT01810445 Completed - Bladder Cancer Clinical Trials

Endoscopic Subsurface Optical Imaging for Cancer Detection

Start date: January 1999
Phase: N/A
Study type: Observational

The purpose of this pilot study is to develop the methodology for an innovative subsurface imaging technology that was designed at Lawrence Livermore National Laboratory. It will allow the non-invasive analysis and imaging of tissues and chemical distributions in the body at an imaging depth of up to 1 centimeter with spatial resolution on the order of 1 mm.

NCT ID: NCT01801644 Completed - Bladder Cancer Clinical Trials

Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

Start date: April 2007
Phase: N/A
Study type: Interventional

To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in locally advanced bladder cancer.

NCT ID: NCT01780545 Completed - Bladder Cancer Clinical Trials

Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer

Start date: April 2013
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label Phase 2 clinical trial to evaluate whether suppression of Hsp27 (Heat shock protein 27) production using OGX-427, a second-generation antisense oligonucleotide (ASO), in combination with docetaxel can prolong survival time compared to docetaxel alone in participants with locally advanced or metastatic urothelial carcinoma (UC) that are relapsed or refractory after receiving a platinum-containing regimen.

NCT ID: NCT01776138 Completed - Bladder Cancer Clinical Trials

Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer

PORCH
Start date: July 23, 2012
Phase:
Study type: Observational

The purpose of this study is to create a registry of older patients undergoing surgical and/or medical treatment for bladder cancer. The registry will record side-effect and outcomes related to the treatment using different surveys and biological measures.

NCT ID: NCT01738815 Completed - Bladder Cancer Clinical Trials

Impact of Valproate on Angiogenesis and Histone Deacetylation in Bladder Cancer

Start date: December 2011
Phase: Early Phase 1
Study type: Interventional

The goal of this study is to test whether the drug valproic acid can cause changes in bladder tumors that might inhibit their growth.

NCT ID: NCT01732107 Terminated - Bladder Cancer Clinical Trials

Dovitinib in BCG Refractory Urothelial Carcinoma With FGFR3 Mutations or Over-expression

Start date: March 2013
Phase: Phase 2
Study type: Interventional

This trial will assess the 6-month complete response rate and toxicity profile of oral dovitinib therapy in BCG-refractory urothelial carcinoma patients with tumors with FGFR3 mutations or over-expression who are ineligible for or refusing cystectomy.

NCT ID: NCT01711112 Completed - Bladder Cancer Clinical Trials

Salvage Docetaxel for Pretreated Urothelial Cancer

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

Based on the previous clinical experience in other cancers, and considering the absence of current standard salvage regimens, the single agent docetaxel is selected as the regimen for this phase II study. Main toxicity of docetaxel is myelosuppression. The low rate of severe myelosuppression observed in other cancer trials warrants further study in urothelial cancer. The objective of the study is to evaluate the safety and activity of weekly docetaxel given as salvage therapy for advanced urothelial cancer.

NCT ID: NCT01710293 Withdrawn - Breast Cancer Clinical Trials

Intervention Protocol for Automated Point-of-Care Surveillance of Outpatient Delays in Cancer Diagnosis

PACT CREATE 3
Start date: January 27, 2017
Phase: N/A
Study type: Interventional

Many missed and delayed cancer diagnoses result from breakdowns in communication and coordination of abnormal findings suspicious for cancer, which often first emerge in the primary care setting. Delays in the follow-up of abnormal test results persist despite the reliable delivery of test results through the electronic health record. This intervention is the final study in a three-phase project that will develop and test an innovative automated surveillance intervention to improve timely diagnosis and follow-up of five common cancers in primary care practice. The investigators hypothesize that the median time in days from diagnostic clue to follow-up action (e.g. time to colonoscopy examination after am abnormal colon-related test) will be significantly less in the intervention arm than in usual care. The investigators also hypothesize that the proportion of patients receiving appropriate and timely follow-up care will be significantly higher in the intervention arm than in usual care.