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Chemotherapy for Bladder Cancer (NAUTICAL Trial)
NAUTICAL Trial Summary
This trial is looking at the feasibility of conducting a larger clinical trial to see if neoadjuvant chemotherapy can help improve survival for people with UTUC.
NAUTICAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNAUTICAL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.NAUTICAL Trial Design
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Who is running the clinical trial?
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- I am considered suitable for major kidney or ureter surgery by a cancer surgeon.I will be evaluated for further chemotherapy after my kidney or ureter surgery.My cancer is in the bladder or urinary tract and has not spread to distant organs.I am 18 years old or older.My blood counts and kidney function are within normal ranges.My doctor agrees I can undergo major surgery for kidney or ureter cancer.I am fully active or can carry out light work.My doctor agrees I can undergo chemotherapy with platinum drugs.I haven't had any cancer or chemotherapy, except for bladder cancer, in the last 2 years.I have only one kidney.My doctor agrees I can handle cisplatin-based chemotherapy.My bladder cancer has not spread into the bladder muscles.My blood counts and kidney function are within normal ranges.My cancer has spread to my lymph nodes and can be seen on scans.I am not pregnant or breastfeeding and will use birth control during and for 6 months after treatment.I am able to get out of my bed or chair and move around.My doctor agrees I can undergo chemotherapy involving platinum.I do not have hearing loss, severe nerve damage, or serious infections.I am fully active or can carry out light work.I am 18 years old or older.My cancer is in the bladder or urinary tract and has not spread to distant parts of my body.I have a new diagnosis of bladder cancer that hasn't spread, confirmed by tests.My blood counts and kidney function are within normal ranges.I have been newly diagnosed with a visible bladder cancer that has not spread.I am able to care for myself and perform daily activities.My doctor agrees I can handle cisplatin-based chemotherapy.My cancer has spread to other parts of my body.My blood counts and kidney function are within normal ranges.
- Group 1: Neoadjuvant Chemotherapy Arm
- Group 2: Adjuvant Chemotherapy Arm (Standard of Care)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Has the FDA given Gemcitabine the green light?
"Gemcitabine's safety is based on Phase 3 trial data, which suggests that the drug is efficacious and has undergone multiple rounds of safety testing."
What conditions does Gemcitabine typically help?
"Commonly, advanced endometrial cancer is treated with Gemcitabine. However, this chemotherapy drug can also be effective for treating melanoma, lymphoma, non-hodgkin, and advanced sarcoma."
Are you still looking for new test subjects for this clinical trial?
"Yes, as of 4/12/2022 this study is still recruiting patients, according to the listing on clinicaltrials.gov. This particular trial was first advertised on 2/8/2021."
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