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Muscle Invasive Bladder Cancer clinical trials

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NCT ID: NCT04687254 Recruiting - Bladder Cancer Clinical Trials

Gender-related Characteristics of Bladder Cancer Treatment

BladderBLOG
Start date: September 1, 2020
Phase:
Study type: Observational

The most frequent cancer of the urinary tract is the bladder cancer (BC), in Italy its incidence reaches the 7% of all the new diagnosis of cancer, accounting for the fifth cause of death in the western countries, overall 140.000 new cases per year in Europe. In the year 2017, the Italian association for medical oncology (AIOM) recorded in our country about 21.700 new diagnosis of BC men and 5.300 in women. This data show not only a relevant gender disparity on the disease incidence (in 5th to 7th decade male incidence: 11-12% of all new diagnosis of cancer versus 1% in women) but also on the outcomes of treatment. Overall, the 30% of all the new diagnosis have a muscle-invasive (MIBC) onset, the female gender suffer a correlation with a more advanced disease at the time of first diagnosis. As a consequence, men have lower BC-related mortality when compared to women (p<0,001). This discrepancy in the mortality rate has been investigated by many authors, resulting in the evidence that female gender suffers higher risks, especially during the first two-years after the radical cystectomy. A comprehensive explanation has not been formulated yet, but a multiplicity of cofactors, including variations in the hormone receptors and tumor biology as well as the different anatomy between male and female, have been identified as potentially relevant. Another important issue in the pre-operatory management of female patients with BC is the misleading interpretation of hematuria. It seems to directly correlate with the evidence that women suffer a more advanced stage at diagnosis, and this element has been withheld in the list of relevant risk factors for prognosis. Nevertheless, a thorough analysis of their effect will only be possible in the future, as well-designed prospective and randomized clinical trials are currently not available. A part from the preoperatory disparity, it has also been described that men are more frequently candidates to an orthotopic urinary diversion, leading female patients to an irreversibly altered perception of personal integrity and body image, namely to a lower quality of life after radical cystectomy. The female anatomy has been considered as a limitation to continence recovery, resulting in preoperative counselling more frequently against in favor of ileal conduit or not-continent urinary diversions.

NCT ID: NCT04660344 Recruiting - Clinical trials for Muscle-invasive Bladder Cancer

A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

IMvigor011
Start date: May 3, 2021
Phase: Phase 3
Study type: Interventional

This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy.

NCT ID: NCT04209114 Completed - Bladder Cancer Clinical Trials

A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer

Start date: February 5, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk urothelial cancer, including muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.

NCT ID: NCT04101812 Recruiting - Clinical trials for Muscle Invasive Bladder Cancer

Pegylated Liposomal Doxorubicin, PD-1 in Treating Muscle Invasive Bladder Cancer

Start date: September 17, 2019
Phase: Phase 2
Study type: Interventional

Despite primary surgical management of muscle invasive bladder cancer (MIBC) with radical cystectomy and pelvic lymphnode dissection, up to 50% of patients will eventually develop tumours at distant sites, owing to pre-existing disseminated occult micrometastases. The first line treatment for relapse or metastatic MIBC is gemcitabine and cisplatin. After the failure of first line treatment, second line chemotherapy drugs can be chosen from doxorubicin, docetaxel, pemetrexed, etc. This non-randomized, prospective study aims to explore the efficacy and safety of PEGylated liposomal doxorubicin and PD-1 in second line treatment of MIBC.

NCT ID: NCT04099589 Recruiting - Clinical trials for Muscle-invasive Bladder Cancer

Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma

Start date: October 1, 2019
Phase: Phase 2
Study type: Interventional

Few previous studies focused on the neoadjuvant treatments of upper urinary or bladder cancer, especially chemotherapy combined with immunotherapy, however, available data of retrospective studies showed this neoadjuvant treatment model might benefit patients. So This prospective Phase II clinical trial was designed to explore the efficacy of chemotherapy combined with PD-1 inhibitor as neoadjuvant therapy in upper urinary and muscle-invasive bladder urothelial carcinoma, then to improve the rate of complete pathological remission, survival and provide medical evidence.

NCT ID: NCT04053101 Active, not recruiting - Clinical trials for Muscle Invasive Bladder Cancer

Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer

TEP Vessie
Start date: April 1, 2017
Phase:
Study type: Observational

Bladder cancer is the seventh cause of cancer mortality in France. Overall survival is poor, between 45 and 50% at 5 years. Optimal staging of lymph nodes and metastasis is crucial for treatment decision of muscle invasive bladder cancer (MIBC). Guidelines do not recommend FDG-Positron Emission Tomography (PET) Computed Tomography (CT), but rather CT for lymph node and metastatic staging, despite its low accuracy. We performed a retrospective analysis of patients undergoing PET CT for localized MIBC in two centers, to help define the utility of PET CT in this setting.

NCT ID: NCT04047693 Recruiting - Clinical trials for Urothelial Carcinoma

Neoadjuvant Dose Dense MVAC in MIBC and Locally Advanced Urothelial Carcinoma

Start date: May 1, 2019
Phase: Phase 2
Study type: Interventional

The objective is to investigate the efficacy and safety of four cycles of ddMVAC with G-CSF support in patients with MIBC and locally advanced UC

NCT ID: NCT03832673 Withdrawn - Clinical trials for Muscle-invasive Bladder Cancer

Pembrolizumab-Epacadostat Combination to Treat Muscle-invasive Bladder UrotheLIAl canceR: PECULIAR Study

PECULIAR
Start date: May 22, 2019
Phase: Phase 2
Study type: Interventional

An open label, monocenter, single-arm, phase 2 study of neoadjuvant pembrolizumab and epacadostat, preceding radical cystectomy, for patients with muscle-invasive bladder cancer.

NCT ID: NCT03773666 Completed - Clinical trials for Muscle Invasive Bladder Cancer

A Feasibility Study of Durvalumab +/- Oleclumab as Neoadjuvant Therapy for Muscle-invasive Bladder Cancer (BLASST-2)

Start date: February 20, 2019
Phase: Phase 1
Study type: Interventional

This research study is studying a new anti-cancer drug durvalumab (MEDI4736) with or without another new anti-cancer drug Oleclumab (MEDI9447) before surgery for bladder cancer. The drugs involved in this study are: - Durvalumab (MEDI4736) - Oleclumab (MEDI9447)

NCT ID: NCT03747419 Recruiting - Bladder Cancer Clinical Trials

Avelumab and Radiation in Muscle-Invasive Bladder Cancer

Start date: December 13, 2018
Phase: Phase 2
Study type: Interventional

This research study is studying the effects of adding a certain type of immunotherapy to standard bladder-directed radiation as a treatment for muscle-invasive urothelial carcinoma of the bladder. The drug in this study is: Avelumab (also known as BAVENCIO®)