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Gemcitabine + Cisplatin for Bladder Cancer
Study Summary
This trial studies gemcitabine hydrochloride and cisplatin as a treatment for bladder cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My surgeon has approved me for major bladder surgery.My bladder tumor is no larger than 5 cm, as confirmed by a bladder examination.I have localized prostate cancer and am on an active surveillance program.I do not have serious heart rhythm problems.I haven't had a heart attack, stroke, or major heart surgery in the last 6 months.I have no cancer history except for certain skin cancers, early-stage cancers I've recovered from, or any cancer I've been free from for 5 years.My cancer has not spread beyond its original location.I have not had radiation therapy to my bladder or prostate.My bladder cancer has been confirmed by a biopsy.I haven't had PD-1/PD-L1 inhibitors or chemotherapy in the last 5 years.I am fully active or can carry out light work.My kidneys are functioning well.I do not have significant hearing loss.I do not have any serious ongoing health or mental health conditions.My bladder cancer has a specific genetic change.I have had a cystoscopy and imaging to stage my cancer.I've finished 4+ cycles of chemotherapy and have my DDR gene results.I do not have significant numbness or tingling in my hands or feet.I do not have HIV, AIDS, or any other active infection.My bladder cancer has spread to the prostate but not into the muscle, confirmed by imaging or examination.My cancer is at a stage where it has grown but not spread to distant parts.I can provide 20 slides of my cancer tissue from before treatment for testing.I had a bladder tumor biopsy within the last 60 days.I haven't had major surgery or radiation therapy in the last 4 weeks.I do not have multiple areas of early-stage cancer; only one area is present.My heart condition does not severely limit my daily activities.
- Group 1: Arm I (gemcitabine, cisplatin, bladder sparing)
- Group 2: Arm II (gemcitabine, cisplatin, cystectomy, chemoradiotherapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How perilous is Radical Cystectomy for those who undergo the procedure?
"Based on the limited evidence of safety, Radical Cystectomy was awarded a score of 2. However, there is not yet any clinical data that confirms its efficacy."
In what contexts is Radical Cystectomy typically recommended?
"Radical Cystectomy is often employed to treat neoplasm metastasis, as well as certain infections and advanced stages of testicular cancer. Additionally, it has been used to address urinary bladder issues."
How many participants are currently engaged in this clinical trial?
"In order to conduct this research, 271 patients meeting the pre-established requirements must sign up. Potential participants can visit The Melanoma and Skin cancer Institute in Englewood or the Cancer Care Center of O'Fallon in Illinois for enrolment."
At what specific sites is this investigation taking place?
"This investigation is taking place in 3 primary sites: The Melanoma and Skin cancer Institute of Englewood, Colorado; the Cancer Care Center of O'Fallon, Illinois; and IHA Hematology Oncology Consultants-Canton in Michigan. Additionally, it is recruiting from a further 100 clinical centres."
Are there still vacancies in the trial for participants?
"Data hosted on clinicaltrials.gov demonstrates that this medical study, which was initially published on August 1st 2018, is actively recruiting participants. Most recently the details were updated at September 25th 2022."
What other experiments have been performed concerning Radical Cystectomy?
"Since 1997, the City of Hope Comprehensive Cancer Center has been researching Radical Cystectomy. To date, 1763 studies have concluded and 1001 are currently recruiting participants; many in Englewood, Colorado."
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