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Intraoperative Radiotherapy for Glioblastoma (INTRAGO-II Trial)
INTRAGO-II Trial Summary
This trial is testing if adding intraoperative radiotherapy (IORT) to standard radiochemotherapy can improve the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM).
INTRAGO-II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowINTRAGO-II Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.INTRAGO-II Trial Design
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Who is running the clinical trial?
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- I do not have any health conditions that doctors say will shorten my life to under 5 years.I do not have fluid leaking from a brain ventricle defect or risk of high radiation dose to vital organs.I have not had chemotherapy for cancer in the last 5 years.I understand the nature and personal implications of participating in this clinical trial.My cancer is in multiple areas or has spread too much to be surgically removed.My brain tumor can be completely removed by surgery.My blood, liver, and kidney functions meet the required levels.My doctor says I can have targeted radiation during surgery.I have been treated with drugs that block blood vessel growth.My diagnosis is glioblastoma based on tissue examination.I refuse to use birth control during the study.I am between 18 and 80 years old.I can care for myself but may need occasional help.I have had radiation therapy to my brain before.I have given my written consent for surgery at least 24 hours before it.
- Group 1: Experimental Arm (A)
- Group 2: Control Arm (B)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any dangers associated with Radiochemotherapy?
"Radiochemotherapy received a score of 3 because there is both efficacy and safety data from Phase 3 clinical trials."
How many test subjects are involved in this experiment?
"In order to run this experiment, the sponsors need a total of 314 patients that meet certain conditions. The trial will be conducted by Carl Zeiss Meditec AG at various locations, two examples being West virginia University and Barrow Neurological Institute."
What is the usual purpose of Radiochemotherapy?
"Radiochemotherapy is not only an effective treatment for nitrosourea, but also other diseases such as advance directives, refractory, advanced mycosis fungoides and refractory neuroblastoma."
Is this study currently looking for new participants?
"The listing on clinicaltrials.gov says that this study is open for recruitment and is currently looking for 314 patients at 6 locations. The trial was created on December 9th, 2016 with the most recent update being from May 17th, 2022."
Is this a groundbreaking clinical trial?
"Radiochemotherapy has been under clinical investigation since 2002. The first trial was sponsored by Schering-Plough and took place in the same year. Sixty patients were enrolled in the study, which ultimately led to Phase 2 drug approval for Radiochemotherapy. As of now, there are 219 active trials involving Radiochemotherapy being conducted in 947 cities across 38 countries."
Is there precedent for this combination of treatments?
"There are a total of 219 clinical trials studying radiochemotherapy, with 25 of those being in the third and final stage. The majority of these trials originate from Seoul and Songpa in South Korea, but there are 4829 locations worldwide where research is being conducted."
Does this research project have an age limit for participants?
"The age range for eligible patients in this trial is 18 to 80 years old."
Could you please estimate the number of hospitals that are running this trial?
"There are 6 enrolling patients for this trial such as West virginia University in Morgantown, Barrow Neurological Institute (SJHMC) in Phoenix, and Long Island Jewish Medical Center, North Shore University Hospital in Lake Success. In addition to these locations, there are 6 other centres where you can participate."
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