Radiation Therapy + Temozolomide for Brain Tumor
Trial Summary
What is the purpose of this trial?
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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 used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with or without temozolomide in treating patients with low-grade glioma. PURPOSE: This randomized phase III trial is studying radiation therapy so see how well it works when given together with or without temozolomide in treating patients with low-grade glioma.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients with uncontrolled seizures despite two different antiepileptic drug regimens are eligible, suggesting that continuing certain medications might be allowed. Please consult with the trial coordinators for specific guidance.
What data supports the effectiveness of the treatment Radiation Therapy + Temozolomide for Brain Tumor?
Research shows that combining intensity-modulated radiation therapy (IMRT) with temozolomide (TMZ) improves outcomes for brain tumors. In patients with glioblastoma multiforme, those receiving this combination had a median survival of 17.4 months, which is better than the 14.6 months seen in a large trial of similar treatments. Additionally, for brain metastases from lung adenocarcinoma, the combination led to a significant objective response rate of 77.8% and improved quality of life.12345
Is the combination of radiation therapy and temozolomide safe for treating brain tumors?
The combination of radiation therapy and temozolomide has been studied for safety in various brain conditions, including brain metastases and gliomas. Common side effects reported include neutropenia (low white blood cell count), anemia (low red blood cell count), vomiting, fatigue, and dizziness, but severe blood-related side effects were not observed. Overall, the treatment is considered safe with manageable side effects.12467
How does the treatment of Radiation Therapy + Temozolomide for Brain Tumor differ from other treatments?
This treatment combines radiation therapy with temozolomide, a drug that enhances the effectiveness of radiation by making cancer cells more sensitive to it. The use of intensity-modulated radiation therapy (IMRT) allows for precise targeting of the tumor, minimizing damage to surrounding healthy tissue, and when combined with temozolomide, it has shown improved response rates and quality of life in patients compared to radiation alone.12489
Research Team
David Schiff, MD
Principal Investigator
University of Virginia
Eligibility Criteria
This trial is for adults with low-grade glioma, a type of brain tumor. Participants must have symptoms like headaches or seizures, show tumor growth on MRIs, or be over 40 years old. They should be in good physical condition and not pregnant. People who only have well-controlled seizures or other specific health issues are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation Therapy
Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5 days a week for 5½ weeks
Chemotherapy
Patients receive concurrent oral temozolomide once daily for 5½ weeks, followed by temozolomide alone every 28 days for 12 courses
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- 3-dimensional conformal radiation therapy
- Intensity-modulated radiation therapy
- Temozolomide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eastern Cooperative Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator