Radiation for Urinary Bladder Cancer
This study is evaluating whether nivolumab and radiation therapy work better than radiation therapy alone in treating patients with urothelial bladder cancer.
See full descriptionAbout the trial for Urinary Bladder Cancer
Treatment Groups
This trial involves 2 different treatments. Radiation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Radiation will improve 1 primary outcome and 7 secondary outcomes in patients with Urinary Bladder Cancer. Measurement will happen over the course of From date of registration to date of first documented disease relapse/progression, or death from urothelial cancer whichever occurs first, assessed up to 12 months.
Who is running the study
Principal InvestigatorPatient Q & A Section
What is urinary bladder cancer?
BUC is one of the leading causes of bladder cancer deaths worldwide. It is most common when it forms in the urinary bladder. A healthy bladder cannot be assumed to not be at risk for BUC.
What are the signs of urinary bladder cancer?
For women, symptoms of bladder cancer are likely to be present before they present to their GP, and will be more likely to occur when symptoms occur while menstruating. Symptoms of urinary tract infections are uncommon in people with bladder cancer, although they may occur in the presence of bladder cancer, especially if symptomatic. Ureteroscopy is the method of choice for bladder cancer screening, and CT scans and MRI scans for investigations of other possible causes. People with bladder cancer may develop symptoms due to complications from treatment or metastatic disease, and treatment will also prevent further complications and symptoms. Prostate cancer is uncommon in men and usually does not cause symptoms, however they may be present when complications, metastatic, or hormonal treatments are used.
Can urinary bladder cancer be cured?
Most patients will have their bladder tumor removed with surgery. For some patients it may also be possible to eradicate the disease with radiation and/or chemotherapeutic medications.
What are common treatments for urinary bladder cancer?
Patients with urothelial carcinoma are frequently managed by multimodal treatment including cytoreductive surgery, chemotherapy, and radiation therapy. In patients operated for upper tract cancer, the likelihood of cure is improved by the use of newer, more sensitive agents including bacilli and human papilloma virus immunotherapy and antiangiogenic therapy. It appears from the review that a single course of chemotherapy can have a high likelihood of cure. In patients with advanced bladder cancer, most would opt for aggressive induction therapy and the use of the most effective agents available. The most important prognostic factors are stage at presentation and extent of disease at initial treatment.
How many people get urinary bladder cancer a year in the United States?
around 35,730 new cases of invasive [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) are diagnosed each year in the United States, making it the third-most common cancer (tumor, not disease) in men. The trend we noted in the incidence data also exists in the prevalence data.
What causes urinary bladder cancer?
Most urinary transitional cell carcinomas originate from squamous metaplasia of the urothelium, which is a reactive change in the bladder mucosa because of exposure to cigarette smoke. The transition of metaplastic urothelium to TCC is likely a multifactorial process involving the loss of the basement membrane and the acquisition of genomic instability.
What are the latest developments in radiation for therapeutic use?
There were a variety of new options in radiation therapy for urological malignancies, none of which showed overwhelming clinical advantage for patients relative to previously available modes.
How serious can urinary bladder cancer be?
Urinary bladder cancer progresses rapidly, with an average survival of 18 months for patients with T1 disease and 6 months for patients with T2 disease. The overall 5-year survival of urinary bladder cancer remains low. Even patients who have complete, or 'curative,' resection, have a significant risk of death from disease recurrence, particularly among those without lymph node and/or distant metastases. The risk of death appears to be related to the extent of lymphadenectomy in surgical resection. Patients' prognoses are even more difficult to predict when the extent of lymphadenectomy is not specified.
Have there been any new discoveries for treating urinary bladder cancer?
Data from a recent study shows that no major breakthrough will be seen until more data become available. No data is available to support the use of the anti-androgen/antiepileptic ketamine, which has been in use to treat urinary bladder cancer, for other indications, and there is a lack of randomized, controlled trials showing any benefit from this drug. It is not recommended for routine treatment; instead, it may be used sparingly for patients with disease that is not responding to conventional chemotherapy.
Is radiation safe for people?
The risk of developing any [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) after radiotherapy is low, with rates similar to age- and smoking history-matched controls. The risks of developing radiation pneumonitis and rectal disease are higher, but still very low. Radiation therapy appears to be a safe modality of treatment for upper urinary tract and anal cancer, but prospective trials are needed to better establish optimal treatment algorithms and dosimetry.
What is radiation?
Radiation therapy can help you control the size of the cancer that started to grow quickly, but it cannot cure the cancer that has already started spreading (metastasizing). It can stop the cancer from getting bigger and spreading further (dying), but it cannot cure it. Doctors will discuss your treatment options, and how well they work for your recovery, with you. You can find out all of this information by entering your exact case in [this online form] (http://www.radiotherapy.org.uk/treatment-information/treatment-information/radiotherapy-case-finding-form/)...
How quickly does urinary bladder cancer spread?
In our series, invasive ureteral cancer has an aggressive malignant behavior. The overall 5-year survival, locally control and metastases-free survival were worse than those seen in the reported series. This suggests that patient stratification to define treatment protocols may be useful.