High-Dose Radiation + Temozolomide for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT or proton beam radiation therapy is more effective than standard-dose radiation therapy with temozolomide in treating glioblastoma.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it does mention that prior chemotherapy for a different cancer is allowed, except for temozolomide. It's best to discuss your current medications with the trial team to get a clear answer.
Is the combination of high-dose radiation and temozolomide generally safe for humans?
Temozolomide, when used with radiation therapy, is generally considered safe but can cause severe myelotoxicity (damage to the bone marrow, which can affect blood cell production) in some cases. It has a lower toxicity profile compared to some traditional chemotherapy drugs, but patients should be monitored for potential side effects.12345
What makes the treatment of high-dose radiation and temozolomide unique for glioblastoma?
This treatment combines high-dose radiation with temozolomide, a chemotherapy drug that makes cancer cells more sensitive to radiation, potentially improving treatment effectiveness. Temozolomide is taken orally and is known for having fewer side effects compared to older chemotherapy drugs, making it a preferred option for patients with newly diagnosed glioblastoma.46789
What data supports the effectiveness of the drug Temozolomide combined with radiation therapy for glioblastoma?
Research shows that combining Temozolomide with radiation therapy is more effective for treating high-grade brain tumors like glioblastoma than using radiation therapy alone. Temozolomide is a chemotherapy drug that has been shown to improve survival rates when used alongside radiation in patients with newly diagnosed glioblastoma.4581011
Who Is on the Research Team?
Minesh P Mehta
Principal Investigator
NRG Oncology
Are You a Good Fit for This Trial?
Adults with newly diagnosed glioblastoma located in the supratentorial compartment, who have undergone surgery and are able to undergo MRI scans. Participants must not have had prior invasive malignancies (except certain skin cancers) within 3 years or any previous chemotherapy for head and neck cancer (excluding temozolomide). They should be free from serious medical conditions that could interfere with the trial, not pregnant, willing to use contraception, and without a history of HIV/AIDS.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo radiation therapy (either standard-dose photon irradiation or dose-escalated photon IMRT/proton beam therapy) with concomitant temozolomide for 23-30 fractions over 5 days a week, followed by adjuvant temozolomide for up to 12 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up visits every 3 months for 1 year, every 4 months for another year, and then every 6 months thereafter.
What Are the Treatments Tested in This Trial?
Interventions
- Photon Beam Radiation Therapy
- Proton Beam Radiation Therapy
- Temozolomide
Photon Beam Radiation Therapy is already approved in United States, European Union, Canada for the following indications:
- Cancer treatment, including glioblastoma
- Cancer treatment, including glioblastoma
- Cancer treatment, including glioblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
NRG Oncology
Lead Sponsor
Radiation Therapy Oncology Group
Collaborator
National Cancer Institute (NCI)
Collaborator