Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed Glioblastoma (NCT04019262) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed Glioblastoma
United States2 participantsStarted 2021-12-14
Plain-language summary
This is a prospective, randomized, open-label, exploratory trial of temozolomide-based chemo-radiotherapy which compares two widely used established radiation schedules with either 40 Gy in 15 fractions or 25 Gy in 5 fractions with concurrent temozolomide for both schedules in patients with glioblastoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Each patient must meet all of the following inclusion criteria for study enrollment:
* Age ≥18 with ability to provide written informed consent
* Pathologically confirmed WHO Grade IV Gliobastoma prior receiving radiotherapy
* Prior radiotherapy to a dose of ≥50Gy
* No signs of distant metastases
* Baseline laboratory assessment including CBC and blood chemistry, ANC \> or equal 1500, Platelet count greater or equal 100. Liver function tests and creatinine not greater than twice ULN.
* Patient should not be pregnant. Urine or blood β-HCG within 14 days prior to study start for females who are not atleast one year post-menopausal or who have ot undergone a surgical sterilization procedure
* A baseline MRI scan of the brain is required to determine how much tumor is present for properly planning patient's radiotherapy.
* Karnofsky Performance Status (KPS) below 60 or ECOG of 3 or 4
* Any number or type of prior chemotherapy is allowed (patient may receive concurrent or adjuvant systemic therapy such as cetuximab at the discretion of the treating oncologic team).
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not eligible for enrollment:
* Evidence of distant metastases on any staging or imaging modality
* Women who are breast feeding, or have a positive pregnancy test (reproductive age should use effective birth control during study)
* Any co-morbidity or condition of sufficient severity to limit full compliance with th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.