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Aktiv, aber nicht rekrutierendPHASE2INTERVENTIONELL

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.

Auf einen Blick

Status
Aktiv, aber nicht rekrutierend
Phase
PHASE2
Sponsor
Kanadische Krebsstudiengruppe
Einschreibeziel
82
Starten
25 Oct 2019
Geschätzte Fertigstellung
31 Dez 2026

Worum geht es in dieser Studie?

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.

Wichtige Erkenntnisse

  • 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.
  • Die Teilnahme ist freiwillig, und Sie können jederzeit zurücktreten.

Wer könnte berechtigt sein?

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.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. Sind Sie 18 Jahre oder älter?
  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?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

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.

Potenzielle Risiken und Vorteile

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.

Standorte (31)

  • Tom Baker Krebszentrum
    Verifizierte Postleitzahl
    Calgary, Kanada
  • Cross Cancer Institute
    Verifizierte Postleitzahl
    Edmonton, Kanada
  • BCCA - Vancouver Cancer Centre
    Verifizierte Postleitzahl
    Vancouver, Kanada
  • Gesundheitswissenschaften Nord
    Verifizierte Postleitzahl
    Greater Sudbury, Kanada
  • Juravinski-Krebszentrum bei Hamilton Health Sciences
    Verifizierte Postleitzahl
    Hamilton, Kanada
  • Kingston Gesundheitswissenschaftliches Zentrum
    Verifizierte Postleitzahl
    Kingston, Kanada
  • London Regionales Krebsprogramm
    Verifizierte Postleitzahl
    London, Kanada
  • Stronach Regionales Gesundheitszentrum in Southlake
    Verifizierte Postleitzahl
    Newmarket, Kanada
  • Ottawa Hospital Forschungsinstitut
    Verifizierte Postleitzahl
    Ottawa, Kanada
  • Thunder Bay Regional Health Sciences Centre/
    Verifizierte Postleitzahl
    Thunder Bay, Canada
  • University Health Network
    Verifizierte Postleitzahl
    Toronto, Kanada
  • The Jewish General Hospital
    Verifizierte Postleitzahl
    Montreal, Kanada

Häufige Fragen

What is durvalumab?

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

Wer kann an dieser Studie teilnehmen?

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.

Wie lange wird die Studie dauern?

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

Wie Sie mehr erfahren können

Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.

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