A multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy of valganciclovir as add-on therapy in glioblastoma patients
This research study is investigating a new approach for people diagnosed with glioblastoma, a serious type of brain tumour. We want to find out if adding a medication called valganciclovir to the usual treatment helps patients live longer. Some patients will receive valganciclovir, while others will get a placebo (a pill that looks the same but contains no active drug). This helps us fairly compare the effects. The main goal is to see if the group taking valganciclovir lives longer overall. We're also looking at other things like safety and any side effects. The study will follow patients for at least 30 months from when they have surgery to remove the tumour.
At a glance
What is this study about?
This study is about a type of brain tumour called glioblastoma. When someone is diagnosed with glioblastoma, doctors usually recommend surgery to remove as much of the tumour as possible, followed by other treatments. This study wants to see if adding an extra medication, called valganciclovir, to these standard treatments can improve how long people with glioblastoma live.
To make sure the study is fair, some patients will receive valganciclovir, while others will get a 'placebo'. A placebo looks just like the real medicine but doesn’t contain any active drug. Neither the patients nor their doctors will know who is getting the actual drug and who is getting the placebo. This helps us get unbiased results about whether valganciclovir actually works.
The main thing we want to find out is if patients taking valganciclovir live longer than those taking the placebo. We will track how long patients live from the time they have their tumour removed until any reason for their death. We also want to understand if valganciclovir causes any new side effects or helps with other aspects of treatment. The study will continue until the last patient has been followed for at least 30 months.
Key takeaways
- It's a study looking at an extra drug, valganciclovir, for glioblastoma.
- The main goal is to see if this drug helps people live longer.
- Some patients get the real drug, others get a dummy pill (placebo).
- Neither you nor your doctor will know which one you're taking.
- Participation involves regular clinic visits and tests.
- You can stop taking part at any time without affecting your care.
Who may be eligible?
This study is open to adults who have recently been diagnosed with a specific type of brain tumour called glioblastoma. You must be at least 18 years old to take part.
Doctors will also need to check that your tumour is small enough after surgery (less than 1 cubic centimetre of the enhanced part of the tumour remaining). This helps make sure everyone in the study has a similar starting point.
Beyond these main points, the study doctors will go through a full list of criteria to make sure this study is the right fit for you. They will consider your overall health and other medical conditions to ensure your safety if you participate.
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.
- Are you at least 18 years old?
- Have you recently been diagnosed with glioblastoma WHO grade IV?
- Has your doctor confirmed that less than 1 cm3 of the tumour remains after surgery?
- Are you able to take oral medication regularly?
What does participation involve?
If you decide to take part in this study, you will be given either valganciclovir or a placebo pill to take alongside your usual glioblastoma treatment. You will be asked to take these pills regularly as instructed by the study team.
You will have regular visits to the clinic so doctors can monitor your health, check for any side effects, and see how your treatment is progressing. These visits will likely include physical examinations, blood tests, and scans to check the tumour. You will also be asked to report any new symptoms or concerns.
The study aims to follow patients for at least 30 months from the time of their surgery. The exact number of visits and the total duration for each individual might vary, but the study team will provide you with a detailed schedule if you join.
Potential risks and benefits
Locations (2)
- —UnverifiedSweden
- —UnverifiedNorway
Common questions
What is glioblastoma?
Glioblastoma is a serious type of fast-growing cancer that forms in the brain.
What is 'standard therapy'?
Standard therapy refers to the usual and most accepted treatments currently available for glioblastoma, which often include surgery, radiation, and chemotherapy.
What is a placebo?
A placebo is a 'dummy pill' that looks exactly like the study drug but doesn't contain any active medication. This helps researchers compare the real drug's effects fairly.
Will I know if I'm getting the drug or the placebo?
No, neither you nor your doctors will know if you are receiving valganciclovir or the placebo. This is called 'double-blinded' and helps ensure the study results are fair.
How long will the study last for me?
The study aims to follow patients for at least 30 months from their surgery date, though individual participation might vary slightly.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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