Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme
This study is for adults newly diagnosed with a serious type of brain tumour called glioblastoma. Researchers want to find out if giving a special dose of radiation during surgery, called intraoperative radiotherapy (IORT), can improve how long patients live without their cancer returning. This will be compared to the current standard treatment, which involves surgery followed by a combination of radiation and chemotherapy. Participants will be randomly assigned to one of two groups: one receiving standard treatment, and the other receiving IORT in addition to standard treatment. The study is a Phase III trial, meaning it's a large study comparing a new treatment to an existing one to see which is more effective. The goal is to see if adding IORT offers a significant benefit for patients with glioblastoma.
At a glance
What is this study about?
This research study is about finding better ways to treat a serious type of brain tumour called glioblastoma. When someone is diagnosed with glioblastoma, they usually have surgery to remove as much of the tumour as possible. After surgery, the standard treatment is a combination of radiotherapy (using high-energy rays to kill cancer cells) and chemotherapy (using powerful drugs). This study wants to see if adding a special type of radiation, called 'intraoperative radiotherapy' (IORT), during the surgery itself can make a difference.
IORT means that directly after the surgeon has removed the tumour, a single, targeted dose of radiation is given to the area where the tumour was. The idea is to target any remaining cancer cells in that area right away. This study will compare two approaches: either receiving the standard treatment mentioned above, or receiving IORT during surgery *in addition to* the standard radiotherapy and chemotherapy afterwards. The main goal is to see if adding IORT can help people with glioblastoma live longer without their cancer growing back.
This is a 'Phase III' trial, which means it's a large and important study. It's designed to definitively compare a new treatment (IORT plus standard care) against the existing standard care. Finding more effective treatments for glioblastoma is very important, and studies like this help medical experts understand the best ways to fight these challenging cancers.
Key takeaways
- This study evaluates adding radiation during brain tumour surgery for glioblastoma.
- It compares this new approach to standard treatment (surgery, radiotherapy, chemotherapy).
- The main goal is to see if this addition helps patients live longer without their cancer returning.
- Participants will be randomly assigned to one of two treatment groups.
- The study is for adults aged 18-80 with newly diagnosed glioblastoma.
- Your doctors will check if you meet all the health and tumour-related requirements.
Who may be eligible?
To join this study, you need to be an adult between 18 and 80 years old, diagnosed with a specific type of glioblastoma that doctors believe can be fully removed by surgery. You also need to be generally well enough to undergo surgery and treatment, which doctors will assess using a common health score. Your organs, like your blood, liver, and kidneys, need to be working well, as checked by blood tests.
There are also some reasons why you might not be able to join. For example, if your tumour is spread out in multiple places, or if you've already had radiation treatment to your head. You also can't have participated in other cancer drug studies recently, or have certain other serious health conditions that would greatly limit your life expectancy. Importantly, you can't be pregnant or breastfeeding, and if you can get pregnant, you'd need to agree to use reliable birth control during the study.
Finally, the technical aspects of the surgery and the IORT procedure need to be suitable. The surgical team will confirm if IORT can be safely and effectively delivered in your specific case. Your doctors will discuss all these points with you to see if the study might be 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.
- Have I been diagnosed with glioblastoma?
- Am I between 18 and 80 years old?
- Am I generally well enough for surgery and treatment?
- Have I not had previous radiation treatment to my head?
- Am I not pregnant or breastfeeding?
- Do I agree to use reliable contraception if I can get pregnant?
What does participation involve?
If you decide to join this study, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive the standard treatment for glioblastoma, which involves surgery followed by a combination of radiotherapy and chemotherapy with a drug called temozolomide. The other group will receive the same standard treatment, but they will also have an extra step: a special dose of radiation given directly during their surgery.
Before surgery, you'll have various tests to check your health and confirm your eligibility. After surgery and the initial course of radiotherapy and chemotherapy, you will have regular follow-up appointments, including scans, to monitor your health and how the treatment is working. These appointments will continue over a period of time, as outlined by the study team, to track your progress and any potential changes.
Potential risks and benefits
Locations (19)
- Barrow Neurological Institute (SJHMC)Verified postcodePhoenix, United States
- Stritch School of Medicine Loyola UniversityVerified postcodeMaywood, United States
- Long Island Jewish Medical Center, North Shore University HospitalVerified postcodeLake Success, United States
- Lenox Hill Hospital, Hofstra Northwell School of MedicineVerified postcodeNew York, United States
- West Virginia UniversityVerified postcodeMorgantown, United States
- Hospital Alemão Oswaldo CruzVerified postcodeSão Paulo, Brazil
- Montreal Neurological Institute and HospitalVerified postcodeMontreal, Canada
- Beijing Tian Tan Hospital, Capital Medical UniversityVerified postcodeBeijing, China
- University Hospital AugsburgVerified postcodeAugsburg, Germany
- Charité - UniversitätsmedizinVerified postcodeBerlin, Germany
- St. Georg HospitalVerified postcodeLeipzig, Germany
- University Hospital MannheimVerified postcodeMannheim, Germany
Common questions
What is Glioblastoma?
Glioblastoma is a serious type of brain tumour that grows quite quickly.
What is Intraoperative Radiotherapy (IORT)?
IORT is a special dose of radiation given directly to the tumour area during your surgery, right after the tumour has been removed.
Will I know which treatment group I am in?
Yes, this is an 'open-label' study, meaning both you and your doctors will know if you are receiving IORT or just the standard treatment.
How long will the study last for me?
While the exact duration of your follow-up will be discussed, studies like this often involve long-term monitoring for several years.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time without giving a reason, and it won't affect your medical care.
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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