All studies
Active not recruitingPHASE3INTERVENTIONAL

Treatment Intensification With Temozolomide in Adults With a Glioblastoma

This study is looking at adults who have been newly diagnosed with a type of brain tumour called glioblastoma. Doctors want to find out the best way to give a chemotherapy drug called temozolomide (TMZ). The study compares two treatment plans. One plan is the standard treatment, which involves radiation therapy alongside TMZ, followed by 6 cycles of TMZ. The other plan is more intensive: TMZ starts earlier and continues for a longer period, unless there are side effects, the cancer gets worse, or the patient decides to stop. The aim is to see if this more intensive approach can improve outcomes for patients.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Centre Oscar Lambret
Enrolment target
486
Start
13 Mar 2019
Estimated completion
01 Jun 2027

What is this study about?

This study is looking into a type of brain tumour called glioblastoma, which is a serious condition. When someone is diagnosed, their doctors often recommend surgery to remove as much of the tumour as possible, followed by a treatment plan using radiation and a chemotherapy drug called temozolomide (or TMZ).

However, doctors aren't completely sure about the very best way to give TMZ alongside radiation – specifically, when to start it and how long to continue it for after the initial treatment. This study aims to answer those questions. It compares two approaches: the standard way of giving TMZ, which has been shown to be effective, and a new, more intensive way. In the intensive approach, TMZ would be started earlier and continued for a longer time, as long as it's safe and well-tolerated. Researchers want to see if this intensified plan works better than the standard approach.

The main goal is to find out if the intensified treatment can lead to better results for people with glioblastoma. This is a "Phase 3" trial, which means it's a large study designed to confirm if a new treatment approach is better than the current standard. By taking part, patients are helping doctors learn more about glioblastoma and potentially improve future treatments.

Key takeaways

  • The study compares two ways of giving chemotherapy for glioblastoma.
  • One way is the standard treatment, the other is more intensive (earlier and longer TMZ).
  • It's for adults newly diagnosed with glioblastoma.
  • The goal is to find out if the intensive treatment improves outcomes.
  • You'll get close monitoring and care if you participate.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been recently diagnosed with a **newly developed** glioblastoma. This diagnosis must be confirmed by a doctor after surgery or a biopsy. You should also be well enough to take part, meaning you can generally look after yourself, even if you have some weakness from the tumour. Your body should also be working well enough, as checked by blood tests.

There are also some reasons why you might not be able to join. For example, if your glioblastoma has come back after treatment, or if you've had certain other cancers recently. You also can't be pregnant or breastfeeding, or have certain other serious medical conditions like a recent severe blood disorder or specific infections like HIV or hepatitis. Your doctors will go through all these details carefully with you to see if the study is a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been newly diagnosed with glioblastoma?
  3. Is your KPS score 60% or higher, or is your main issue weakness from the tumour?
  4. Are you able to take oral medications?
  5. Are you or your partner using effective contraception if sexually active?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first sign a consent form, showing you understand and agree to participate. You would then be assigned to one of two treatment groups by chance (like flipping a coin). One group will receive the standard treatment for glioblastoma, which involves radiation therapy and the chemotherapy drug temozolomide (TMZ), followed by six cycles of TMZ.

The other group will receive an intensified treatment. This means you would receive TMZ earlier and continue it for a longer period of time, unless you experience significant side effects, your cancer progresses, or you decide to stop the treatment. Both groups will receive radiation therapy. You will have regular appointments with your study doctors and nurses, including check-ups, blood tests, and scans, to monitor your health and how the treatment is working. The total length of your participation would depend on your treatment plan and how you respond to it, potentially continuing for several months or longer while on TMZ and for follow-up.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new, potentially more effective treatment approach or very close monitoring of your health and treatment. However, all medical treatments carry risks. The medicines used in this study, such as chemotherapy and radiation, have known side effects that your doctors will explain. The intensified treatment might mean you experience these side effects for a longer period. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (17)

  • Centre Hospitalier d'Amiens
    Verified postcode
    Amiens, France
  • Centre François Baclesse
    Verified postcode
    Caen, France
  • Centre Jean Perrin
    Verified postcode
    Clermont-Ferrand, France
  • Hôpitaux Civils de Colmar
    Verified postcode
    Colmar, France
  • Centre Georges François Leclerc
    Verified postcode
    Dijon, France
  • CHU Grenoble Alpes
    Verified postcode
    Grenoble, France
  • CHU de Limoges
    Verified postcode
    Limoges, France
  • Centre Léon Bérard
    Verified postcode
    Lyon, France
  • CHU La Timone
    Verified postcode
    Marseille, France
  • ICM Val d'Aurelle
    Verified postcode
    Montpellier, France
  • CHRU Nancy
    Verified postcode
    Nancy, France
  • CHU de Nice - Hôpital de Cimiez
    Verified postcode
    Nice, France

Common questions

What is glioblastoma?

Glioblastoma is a type of aggressive brain tumour that starts in the brain tissue.

What is temozolomide (TMZ)?

TMZ is a chemotherapy medicine often used to treat glioblastoma. It helps to slow down or stop the growth of cancer cells.

What does 'intensified protocol' mean?

It means a new way of giving the temozolomide, starting it earlier and continuing it for a longer time than usual, to see if it works better.

Will I know which treatment I'm getting?

Yes, this study is 'open-label', meaning you and your doctors will know which treatment plan you are following.

Can I leave the study at any time?

Yes, you can absolutely choose to leave the study at any point without it affecting your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.