Trial comparing treatments for Glioblastoma, IDH-Wildtype
Official title Temporally-Modulated Pulsed Radiation Therapy Versus Standard Radiation Therapy for the Treatment of Newly Diagnosed, IDH Wildtype, MGMT-Unmethylated Glioblastoma
ClinicalTrials.gov ID: NCT07452458
What this study is testing
What is Temozolomide?
An investigational oral chemotherapy drug being studied for newly diagnosed glioblastoma. It is designed to damage the DNA of cancer cells.
Also referred to as Temodar.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if the pulsed radiation, given with breaks, can improve survival and keep memory and thinking better than the usual radiation. It also looks at whether adding the drug temozolomide works better with the pulsed schedule.
- Who it's for
- It is looking for adults who have just had surgery for a newly diagnosed glioblastoma that is IDH‑wildtype and MGMT‑unmethylated.
- What's involved
- Participants will receive the same total amount of radiation as in standard care, but it will be split into 10‑13 pulses with 3‑minute breaks between each pulse. Many will also take the chemotherapy drug temozolomide. They will have regular visits for treatment, imaging, and tests of memory and thinking.
- Time commitment
- The treatment lasts about 6 weeks of radiation, with additional visits for follow‑up scans and cognitive testing over the next several months.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- No known IDH mutation. (If tested before step 1 registration, patients known to have IDH mutation in the tumor on local or other testing are...
- Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block and hematoxylin and eosin (H\&E) stained slide to be sent for central...
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to Step 1 registration.
- No known leptomeningeal disease or metastatic disease outside the brain.
- Age ≥ 18
See the full eligibility criteria
- No known IDH mutation. (If tested before step 1 registration, patients known to have IDH mutation in the tumor on local or other testing are ineligible and should not be registered).
- Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block and hematoxylin and eosin (H\&E) stained slide to be sent for central pathology review for confirmation of histology and MGMT promoter...
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to Step 1 registration.
- No known leptomeningeal disease or metastatic disease outside the brain.
- Age ≥ 18
- Because neurocognitive testing is the primary goal of this study, patients must be proficient in English or French Canadian.
- Karnofsky Performance Status ≥ 70
- Hemoglobin ≥ 10 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 10.0 g/dl is acceptable)
- Leukocytes ≥ 2,000/mm\^3 OR absolute neutrophil count ≥ 1,500/mm\^3
- Platelets ≥ 100,000/mm\^3
- Creatinine clearance (CrCl) ≥ 50 mL/min
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase [SGPT]) ≤ 3 x ULN
- No prior cranial radiation therapy that would result in overlap of radiation therapy fields.
- No previous therapy for GBM except surgery, laser interstitial thermal therapy (LITT) or Gliadel wafer.
- Note: 5-aminolevulinic acid (ALA)-mediated fluorescence-guided resection (FGR) photodynamic therapy (PDT) or fluorescein administered prior to/during surgery to aid resection is not exclusionary and is not considered a...
- No history of unstable angina requiring hospitalization in the last 3 months
- No history of myocardial infarction within the last 3 months
- New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of...
- No active infection currently requiring IV antibiotic management
- No chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy
- No movement disorder that could impede ability to lie still with an immobilization mask for approximately 40 minutes
- No significant sensory deficits (i.e., blindness, mutism) that would prohibit participation of NCF testing
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to temozolomide
- The following baseline neurocognitive tests must be completed within 28 days prior to Step 2 registration: (Hopkins Verbal Learning Test - Revised [HVLT-R], Trail Making Test [TMT], Controlled Oral Word Association...
- NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.
- Note: Patients whose neurocognitive test scores do not meet the criteria above will not be eligible for the study and will be reported as ineligible due to "Failure to meet Neurocognitive testing criteria" on Step 2...
- Pathology proven diagnosis of IDH-wildtype glioblastoma with unmethylated MGMT promoter confirmed by central pathology review.
- Central pathology review will generally be completed within 10 business days of receipt of the tissue. Users with the Rave CRA role will be able to view the results in Rave.
- Note: Patients with tissue that is insufficient or inadequate for analysis, has failed MGMT testing, or has indeterminate or methylated MGMT promoter are excluded and will be reported as a "central pathology review...
The study team makes the final eligibility decision.
Where it is enrolling
- Irvine, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Sacramento, California, United States
- Grand Junction, Colorado, United States
- Alton, Illinois, United States
- Decatur, Illinois, United States
- DeKalb, Illinois, United States
- Geneva, Illinois, United States
- O'Fallon, Illinois, United States
- Shiloh, Illinois, United States
- Warrenville, Illinois, United States
- Ankeny, Iowa, United States
- Carroll, Iowa, United States
- Clive, Iowa, United States
- Des Moines, Iowa, United States
- Pella, Iowa, United States
- Waukee, Iowa, United States
- Kansas City, Kansas, United States
- Overland Park, Kansas, United States
+ 23 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Irvine, California, United States; Los Angeles, California, United States; Orange, California, United States; Sacramento, California, United States; Grand Junction, Colorado, United States; Alton, Illinois, United States and 37 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.