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Activo, no reclutandoFASE2INTERVENCIONISTA

Trimodality Therapy With/Out Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer

This study aims to find out if a medicine called durvalumab can help people with muscle-invasive bladder cancer. Participants will have already finished a combination of treatments, which include surgery, chemotherapy, and radiotherapy. Durvalumab is a type of immunotherapy that works by helping your body's immune system recognise and fight cancer cells more effectively. Researchers want to see if adding durvalumab after these standard treatments can help slow down the cancer's growth or cause cancer cells to die. It's currently unclear if this extra step is beneficial for bladder cancer patients who have already completed other therapies.

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Estado
Activo, no reclutando
Fase
FASE2
Patrocinador
Canadian Cancer Trials Group
Objetivo de inscripción
82
Inicio
25 Oct 2019
Estimación de finalización
31 Dic 2026

¿De qué trata este estudio?

This study is looking into a new approach for treating bladder cancer, specifically for people whose cancer has grown into the muscle of the bladder. This type of cancer is called muscle-invasive bladder cancer. Many people with this cancer will have a combination of treatments, which might include surgery, chemotherapy, and radiotherapy. These treatments are often given one after the other, or sometimes together. While these treatments are effective for many, researchers are always looking for ways to improve outcomes and give patients the best chance of recovery.

The main idea behind this study is to see if adding a drug called durvalumab *after* you've already completed your surgery, chemotherapy, and radiotherapy, can make a difference. Durvalumab is a type of medicine known as immunotherapy. Immunotherapy works by helping your body's own immune system become stronger and better at finding and fighting cancer cells. Think of it like giving your immune system a boost to recognise the cancer as a threat and attack it.

We know durvalumab has been tested in other types of cancer and has shown promise in helping the immune system reactivate and detect cancer. For bladder cancer, we want to understand if using durvalumab after standard treatments can help slow down the cancer's growth, or even cause cancer cells to die. At the moment, we don't know for sure if adding durvalumab at this stage will be helpful for people with bladder cancer who have completed their initial treatments, which is why this study is so important.

Puntos clave

  • This study explores a new treatment option for bladder cancer.
  • It tests an immunotherapy drug called durvalumab after standard treatments.
  • The goal is for the immune system to better fight cancer cells.
  • It's for people who have completed surgery, chemotherapy, and radiotherapy.
  • La participación es voluntaria, y puedes retirarte en cualquier momento.

¿Quién puede ser elegible?

To be part of this study, you would generally need to have been diagnosed with bladder cancer that has grown into the muscle layer (muscle-invasive bladder cancer). The cancer should not have spread to other parts of your body, which doctors call metastatic disease. You must be at least 18 years old, generally fit and well enough to take part, and weigh more than 30 kilograms.

A key requirement is that you will have already completed your initial treatment for bladder cancer, which includes surgery, chemotherapy, and radiotherapy. It's important that you are able to start the study treatment within six weeks after finishing your previous treatments. You will also need to have healthy enough blood counts, kidney function, and liver function.

Your doctors will need to check your medical records, including details of your bladder cancer diagnosis and previous treatments, to ensure you meet all the necessary requirements for the study. There are specific criteria regarding the type of bladder cancer you have, and certain prior treatments that might mean you can't join.

¿Podría este estudio ser adecuado para ti?

Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.

  1. ¿Tienes 18 años o más?
  2. Do you have muscle-invasive bladder cancer that hasn't spread?
  3. Have you already completed surgery, chemotherapy, and radiotherapy for your bladder cancer?
  4. Are you generally well and fit enough for treatment?
  5. Can you start the study treatment within about 6 weeks of finishing your previous treatments?
Responde cada pregunta para ver tu resultado.

¿En qué consiste la participación?

If you decide to take part in this study, you would receive the drug durvalumab after you've finished your initial treatment of surgery, chemotherapy, and radiotherapy. The exact schedule for taking durvalumab and how long you'd be on it would be explained by the study team. You would have regular appointments at the hospital for check-ups, blood tests, and to receive the study drug, which is usually given through a drip.

These appointments are important to monitor your health, see how you're responding to the treatment, and check for any side effects. The study team will tell you how often these visits will be and what tests you'll have. The total duration of your participation in the study, including treatment and follow-up, will be clearly outlined by the researchers.

Riesgos y beneficios potenciales

Taking part in any study has potential benefits and risks. A potential benefit of this study is that durvalumab might help your immune system fight your bladder cancer more effectively, potentially slowing its growth or causing cancer cells to die. However, it's important to remember that we don't yet know if this will be the case for bladder cancer, as this is what the study aims to find out. As with any medication, durvalumab can have side effects, which the study team will discuss with you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (31)

  • Tom Baker Cancer Centre
    Código postal verificado
    Calgary, Canadá
  • Instituto Oncológico Cross
    Código postal verificado
    Edmonton, Canadá
  • BCCA - Vancouver Cancer Centre
    Código postal verificado
    Vancouver, Canadá
  • Health Sciences North
    Código postal verificado
    Greater Sudbury, Canada
  • Juravinski Cancer Centre at Hamilton Health Sciences
    Código postal verificado
    Hamilton, Canadá
  • Kingston Health Sciences Centre
    Código postal verificado
    Kingston, Canada
  • London Regional Cancer Program
    Código postal verificado
    Londres, Canadá
  • Stronach Regional Health Centre at Southlake
    Código postal verificado
    Newmarket, Canada
  • Ottawa Hospital Research Institute
    Código postal verificado
    Ottawa, Canada
  • Thunder Bay Regional Health Sciences Centre/
    Código postal verificado
    Thunder Bay, Canada
  • University Health Network
    Código postal verificado
    Toronto, Canadá
  • The Jewish General Hospital
    Código postal verificado
    Montreal, Canadá

Preguntas comunes

What is durvalumab?

Durvalumab is a medicine that helps your body's immune system recognise and fight cancer cells.

¿Quién puede unirse a este estudio?

This study is for adults with muscle-invasive bladder cancer who have already finished surgery, chemotherapy, and radiotherapy.

What does 'trimodality therapy' mean?

It means receiving three types of treatment: surgery, chemotherapy, and radiotherapy for your cancer.

Will I still get my usual cancer care if I don't join?

Yes, taking part in a study is completely voluntary and will not affect your standard medical care either way.

¿Cuánto tiempo durará el estudio?

The study team will tell you the expected length of treatment and follow-up during your discussions with them.

Cómo obtener más información

Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.

Discusión

Discusión comunitaria

Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.