CLINICAL TRIAL

TAS 102 for Urinary Bladder Cancer

Locally Advanced
Metastatic
Recruiting · 18+ · All Sexes · Fairway, KS

This study is evaluating whether a drug may help treat cancer.

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About the trial for Urinary Bladder Cancer

Eligible Conditions
Bladder Cancer, Cancer · Urinary Bladder Neoplasms

Treatment Groups

This trial involves 2 different treatments. TAS 102 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.
TAS 102
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
TAS-102
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Participants with measurable disease must have at least one lesion that can be accurately measured in at least one dimension. show original
Patient is ineligible for a checkpoint inhibitor because they have a documented progression on a prior checkpoint inhibitor or they are not eligible to receive a checkpoint inhibitor show original
The study participant is able to understand the study and has given consent in writing. show original
In order to participate in the study, people must have bladder cancer that is advanced and not able to be surgically removed show original
of chemotherapy The person has to have had documented progress on or within 12 months of treatment with one previous platinum-containing regimen, or be ineligible to receive a platinum-containing regimen show original
People who could potentially have children must either abstain from sex or use two forms of contraception. show original
Men who could potentially have children must not father a child or donate sperm while on this study and for 6 months after their last study treatment. show original
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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 26 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 26 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 26 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 TAS 102 will improve 1 primary outcome and 5 secondary outcomes in patients with Urinary Bladder Cancer. Measurement will happen over the course of Up to 6 months.

Progression-free survival rate (PFS) among participants
UP TO 6 MONTHS
Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
UP TO 6 MONTHS
Clinical benefit rate (complete response+ partial response+ stable disease)
UP TO 6 MONTHS
Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
UP TO 6 MONTHS
Overall response rate (ORR) among participants
UP TO 12 MONTHS
Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
UP TO 12 MONTHS
Overall survival rate (OS) among participants
UP TO 12 MONTHS
Evaluated per Medical Record
UP TO 12 MONTHS
Overall change in patient-reported quality of life outcomes
UP TO 26 MONTHS
Evaluated per Functional Assessment of Cancer Therapy - Bladder (FACT-Bl) version 4 - quality of life (QOL) questionnaire scores FACT-Bl total score range is 0-156, derived by the sum of the sub-scales. Higher scores indicate better QOL. FACT-Bl includes five sub-scales: Physical Well-being (PWB), score range of 0-28 Social/Family Well-being (SWB), score range of 0-28 Emotional Well-being (EWB), score range of 0-24 Functional Well-being (FWB), score range of 0-28 Bladder Cancer Subscale (BlCS), score range of 0-48 Note: Negatively stated items are reversed by subtracting the response from "4".
UP TO 26 MONTHS
Proportion of participants with Grade 3 or higher Adverse and Serious Adverse Events
UP TO 26 MONTHS
Evaluated per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
UP TO 26 MONTHS

Patient Q & A Section

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

Can urinary bladder cancer be cured?

Despite the absence of any cure for [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer), there should still be no doubt that such a cure would be a blessing, and would be the culmination of many years of research into the problem, and it could be the dawning of a new era in cancer management.

Anonymous Patient Answer

What are common treatments for urinary bladder cancer?

The common treatment for prostate cancer is surgical resection. For both bladder cancer and prostate cancer, a combination of various multimodal treatments may present an improvement in both PFS and OS.

Anonymous Patient Answer

What are the signs of urinary bladder cancer?

Some symptoms or signs of urinary bladder cancer can be mistaken for other conditions, such as fever, pain in the kidneys or ureters, blood in the urine, frequent urination, or pain when urinating. Symptoms or signs are not specific to urinary bladder cancer, even when many are present. Urinary blood, fever, frequent urination, pain with urination, and unintentional weight loss should all prompt patients with urinary symptoms to have a medical examination, including consideration of urinary bladder cancer.

Anonymous Patient Answer

What causes urinary bladder cancer?

Risk factors for bladder cancer include smoking, alcohol consumption, and occupational exposure to chemicals and radiation. Genetic or inherited factors also seem to have a role in determining the risk of bladder cancer.

Anonymous Patient Answer

How many people get urinary bladder cancer a year in the United States?

Approximately 10,000 cases of urothelial cancer are diagnosed yearly in the US. It is the most common cancer of the urinary tract, most commonly occurring in men, and ranks fifth in mortality from malignant disease.

Anonymous Patient Answer

What is urinary bladder cancer?

Urothelial bladder cancers are the fourth leading cause of deaths in females in the UK. It is now more common in women than in men, and is linked to smoking, particularly over the age of 60. Urinary bladder cancer affects about 11,500 people annually in the UK. The diagnosis is most effective when made at an early stage which is when treatment is likely to be most effective. Treatment has improvements and many bladder cancers can be cured if detected in the early stages. This is of great importance in that many bladder cancers are asymptomatic, and at more advanced stages the outlook is worse and treatment less effective. The treatment options involve surgery, brachytherapy, immunotherapy or other treatments.

Anonymous Patient Answer

How quickly does urinary bladder cancer spread?

As expected, noninvasive [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) tended to spread more slowly than invasive disease. The mean time between radical cystectomy for localized disease and the subsequent need for a second surgery to remove lymph nodes or metastases was more than 9 months. Cancer 2016;122:4799-80. © 2015 American Cancer Society.

Anonymous Patient Answer

Have there been any new discoveries for treating urinary bladder cancer?

Recent developments in the treatment of bladder cancer have been limited to biologic targeted therapies, although several oncologic agents are currently in Phase III clinical trials. Despite a reasonable number of targeted agents, treatment options for bladder cancer remain sparse. Future trials may offer improved patient selection, more effective drug therapies or combinations of agents.

Anonymous Patient Answer

Has tas 102 proven to be more effective than a placebo?

Patients with an untreated urinary tract infection should be tested for bladder cancer before initiating an adjuvant treatment such as BCG or EPI to reduce the risk of death from bladder cancer. BCG immunotherapy should be strongly considered to prevent recurrence in patients with T1G3 bladder cancer and should be considered a viable alternative therapy versus EPI in the treatment of T1G3 bladder cancer after chemotherapy.

Anonymous Patient Answer

What is the primary cause of urinary bladder cancer?

Results from a recent paper demonstrates the importance of urinary [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) and this may help primary care physicians to diagnose and treat urinary bladder cancer patients at the optimal time before tumor progression leads to cancer death.

Anonymous Patient Answer

What are the latest developments in tas 102 for therapeutic use?

As the initial reports suggested, the tumor-related morbidity and mortality are still high, but the patients can tolerate the treatments well without major side effects. More importantly, because it is a safe and effective means for reducing tumor-related organ dysfunction, tas 102 has attracted large amounts of patients and interest from other institutions across the world.

Anonymous Patient Answer

What is the latest research for urinary bladder cancer?

The recent most recent research suggests that bladder cancer can be prevented when patients avoid exposure to known carcinogens and do not smoke. The American Urological Association has called for urgent action by the general population in an effort to prevent bladder cancer.

Anonymous Patient Answer
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