CLINICAL TRIAL

Radiation for Urinary Bladder Cancer

Waitlist Available · 18+ · All Sexes · Detroit, MI

This study is evaluating whether nivolumab and radiation therapy work better than radiation therapy alone in treating patients with urothelial bladder cancer.

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About the trial for Urinary Bladder Cancer

Eligible Conditions
Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 · Stage II Bladder Urothelial Carcinoma AJCC v6 and v7 · Carcinoma · Urinary Bladder Neoplasms · Stage IV Bladder Urothelial Carcinoma AJCC v7 · Carcinoma, Transitional Cell

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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Radiation
RADIATION
Nivolumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation
2005
Completed Phase 3
~990
Nivolumab
FDA approved

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
- Localized urothelial cancer of bladder with presence of transitional cell carcinoma (TCC) component; mixed histologies are allowed Clinical or pathologic stage T2 -T4 disease including T4a and 4b if feasible to treat with radiation therapy Locoregional lymph node metastases are permitted but patients with distant metastases are ineligible; imaging to evaluate for distant metastases should consist of a minimum of computed tomography (CT)/magnetic resonance imaging (MRI) of abdomen/pelvis or CT urogram and a chest x-ray (CXR) or CT chest; patients for which there is clinical suspicion or symptoms of bone metastasis should have a bone scan completed to rule out metastatic disease prior to enrollment on study Agreeable to consider radiation therapy (RT) for the urothelial cancer: patients have to be evaluated by a radiation oncologist and deemed to be candidates for RT
Performance status of 2
Creatinine clearance =< 60 ml/min as calculated by the Cockcroft-Gault formula
Cardiac disease such as New York Heart Association (NYHA) class III or IV heart failure or cardiac ischemia within the last 12 months, grade 2 or greater neuropathy, or other comorbidities based on which patient is not considered a candidate for chemotherapy Alkaline phosphatase =< 3 x upper limit of normal Aspartate aminotransferase (AST) =< 3 x upper limit of normal Alanine aminotransferase (ALT) =< 3 x upper limit of normal Bilirubin < 1.5 x upper limit of normal (ULN) Absolute neutrophil count >= 1500/mm^3 Hemoglobin >= 9 g/dL Platelets >= 100 K/mm^3 Performance score (PS) of 0-2 by Zubrod score Life expectancy of 12 months Willingness to sign informed consent Patients cannot have active autoimmune disease or immunosuppressive conditions Serum creatinine =< 1.5 X institutional ULN or creatinine clearance > 40 ml/min as calculated by the Cockcroft-Gault formula In females with childbearing potential, or men with partners of child bearing potential, willingness to use adequate contraception for a minimum duration of 155 days in females and 215 days in males, after last dose of nivolumab Maximal tumor resection has been performed as feasible
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Progression-free survival (PFS)
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
PFS distribution will be summarized with the Kaplan-Meier (K-M) survivorship estimate. A graph of the K-M curve for PFS will be generated along with the Hall-Wellner 95% confidence band, and a display of the number of patients at risk at several time points, below the X-axis. Summary statistics (12-month PFS rate, median PFS, etc.) will be calculated from the K-M life table, each one with its respective 95% confidence interval (CI).
Metastasis-free survival (MFS)
FROM REGISTRATION TO THE APPEARANCE OF METASTASES OR CANCER RELATED DEATH, ASSESSED UP TO 12 MONTHS
Summary statistics of MFS will be calculated from the K-M life tables. K-M graphs of the censored MFS distributions will also be generated.
Overall survival (OS)
FROM DATE OF REGISTRATION TO DEATH OR LAST FOLLOW UP, ASSESSED UP TO 12 MONTHS
Summary statistics of OS will be calculated from the K-M life tables. K-M graphs of the censored OS distributions will also be generated.
PD-1 and PDL-1 expression analysis using immunohistochemistry (IHC)
UP TO 12 MONTHS
PDL-1 status will be checked on pre-therapy tumor tissue and will be correlated with the primary endpoint.
Overall response rate (ORR)
UP TO 12 MONTHS
ORR will be estimated among the response evaluable patients and among all patients. Frequency distributions of best response will be generated for each of those sets of patients. The point estimate of the ORR will be computed, along with its 95% (Wilson type) CI.
Incidence of adverse events graded per Common Terminology Criteria for Adverse Events version 4.0.
UP TO 12 MONTHS
Frequency distributions of each toxicity type by severity grade will be generated. For a given grade(s), the point estimate of the toxicity rate will be computed, along with its 95% (Wilson type) CI.
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Who is running the study

Principal Investigator
N. V.
Nitin Vaishampayan, MD
Barbara Ann Karmanos Cancer Institute

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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/)...

Anonymous Patient Answer

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.

Anonymous Patient Answer
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