Study on Reduced BCG Dwell-Time for Patients with High-Risk Urothelial Cancer

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What is this study about?

This clinical trial is focused on studying urothelial cancer, a type of cancer that occurs in the urinary system, including the bladder. The treatment being tested is called BCG-medac, which contains BCG (Bacillus Calmette-Guérin) bacteria. This treatment is administered directly into the bladder, a method known as intravesical use. The purpose of the study is to evaluate the effects of a new treatment schedule that reduces the time the medication stays in the bladder during each treatment session.

The study involves a series of once-weekly treatments for six weeks, followed by maintenance therapy for 12 months. The researchers aim to understand how this new schedule affects side effects, how well patients can stick to the treatment plan, and the overall outcomes related to cancer. Participants will receive a total of six initial treatments, and then continue with maintenance treatments over the course of a year.

Throughout the study, the researchers will monitor various outcomes, such as the recurrence of cancer, progression of the disease, and survival rates over two and five years. They will also track the number of treatments each participant receives and any side effects experienced. This information will help determine if the new treatment schedule is effective and safe for patients with high-risk non-muscle invasive bladder cancer (NMIBC).

1 initial visit

Upon joining the study, you will attend an initial visit where the healthcare team will explain the trial process. You will receive detailed information about the study, including the schedule and what to expect during each phase.

During this visit, you will undergo a medical assessment to ensure you meet the study’s eligibility criteria. This may include a review of your medical history and any necessary tests.

2 beginning of treatment

The treatment involves the use of a medication called BCG (Bacillus Calmette-Guérin) bacteria. This medication is administered directly into the bladder through a process known as intravesical use.

You will receive BCG instillations once a week for 6 weeks. Each session involves the introduction of the medication into the bladder, where it remains for a specified period before being released.

3 maintenance therapy

After the initial 6-week treatment, you will enter the maintenance phase. This phase lasts for 12 months and involves additional BCG instillations.

The maintenance therapy is designed to help prevent the recurrence of cancer and involves periodic instillations as determined by the study protocol.

4 follow-up visits

Throughout the study, you will have regular follow-up visits with the healthcare team. These visits are important for monitoring your health and the effectiveness of the treatment.

During these visits, you may undergo various assessments, including physical exams and laboratory tests, to track your progress and address any side effects.

5 completion of study

At the end of the study period, you will have a final visit to assess the overall outcomes of the treatment.

The healthcare team will review your progress and discuss any further steps or recommendations based on the results of the study.

Who Can Join the Study?

Must be above 18 years of age at the time of signing the consent form.
Must have signed the informed consent form, which means you agree to participate after understanding the study details.
Must have a type of bladder cancer called NMIBC (Non-Muscle Invasive Bladder Cancer) and plan to receive a treatment called BCG therapy for 1 year. This includes:
- Ta high grade without CIS (Carcinoma In Situ, a type of cancer that is in its original place).
- CIS with or without previous or current Ta tumors (a type of bladder tumor).
- T1 with or without CIS (T1 indicates a tumor that has grown into the connective tissue beneath the bladder lining).
Must be, according to the investigator’s judgment, able to comply with the trial protocol, meaning you can follow the study’s rules and procedures.
Must have the ability to understand the patient information sheet both orally and in writing.

Who Cannot Join the Study?

Patients with any other type of cancer besides urothelial cancer cannot participate. Urothelial cancer is a type of cancer that occurs in the urinary system.
Patients who are not within the specified age range cannot participate. The age range for this trial is typically adults and older adults.
Patients who are unable to follow the study procedures or adhere to the treatment schedule cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with severe or uncontrolled medical conditions that could interfere with the study cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients with a history of allergic reactions to the study medication or similar drugs cannot participate.
Patients who are unable to provide informed consent cannot participate. Informed consent means understanding the study and agreeing to take part.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Karolinska University Hospital	Solna	Sweden
Aalborg University Hospital	Aalborg	Denmark
Region Midtjylland	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark
Region Oerebro Laen	Orebro	Sweden
Region Sjaelland	Holbæk	Denmark
Sxqirezotkx Udfiubambq Hagwnpuufbsmuub Ghsnulkvskkmzgfvm	Gothenburg	Sweden
Hdfrrc Hyjjemva	Herlev	Denmark
Apkmgd Uoprhxxcqp Hfsgeimd	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	20.01.2021
Iceland	Not recruiting	20.01.2021
Sweden	Not recruiting	20.01.2021

Trial locations

Investigated drugs:

Bcg (Bacillus Calmette-Guérin) Bacteria

BCG is a type of therapy used in the treatment of bladder cancer. It involves placing a liquid containing weakened bacteria directly into the bladder through a catheter. This bacteria is not harmful, but it helps to stimulate the body’s immune system to attack cancer cells in the bladder. In this trial, the focus is on reducing the time the BCG stays in the bladder during each treatment session, which is called dwell time. The goal is to see if this change can reduce side effects, improve how well patients stick to the treatment schedule, and still effectively treat the cancer.

Investigated diseases:

Transitional cell carcinoma

Urothelial cancer – Urothelial cancer is a type of cancer that begins in the urothelial cells lining the bladder, ureters, and other parts of the urinary tract. It typically starts in the bladder and can spread to other areas of the urinary system. The disease progresses as cancerous cells grow and multiply, potentially invading deeper layers of the bladder wall and surrounding tissues. Over time, it may spread to nearby lymph nodes and other organs. The progression can vary, with some cases remaining superficial while others become more invasive. The disease is characterized by changes in the normal function and structure of the affected tissues.

Trial ID:

2023-505936-37-00

NCT ID:

NCT04701151

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Reduced BCG Dwell-Time for Patients with High-Risk Urothelial Cancer

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