Brain Cancer Treatment Trial
Phase III Randomized Study of Concurrent Chemoradiotherapy and Adjuvant Temozolomide With Versus Without Bevacizumab in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma (RTOG 0825)
Purpose
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. Radiation therapy uses high-energy X-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide and radiation therapy are more effective when given together with or without bevacizumab in treating glioblastoma or gliosarcoma.
This randomized phase III trial is studying temozolomide and radiation therapy to compare how well they work when given together with or without bevacizumab in treating patients with newly diagnosed glioblastoma or gliosarcoma.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- No more than 5 weeks since undergoing surgery to remove the tumor
- No recurrent cancer
- No previous chemotherapy for head and neck cancer
- No previous temozolomide, bevacizumab, or Gliadel wafers
- More than 4 weeks since surgery or open biopsy (other than surgery to remove the tumor)
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment/Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
Patients in group one will undergo radiation therapy 5 days a week for 6 weeks. At the same time, they will also receive temozolomide by mouth once a day for up to 7 weeks. Beginning 4 weeks later, patients will receive temozolomide by mouth on days 1-5. Treatment with temozolomide may repeat every 4 weeks for up to 12 courses. Beginning in week 4 of radiation therapy, patients will also receive a 30- to 90-minute infusion of a placebo every 2 weeks until finishing temozolomide.
Patients in group two will undergo radiation therapy 5 days a week for 6 weeks. At the same time, they will also receive temozolomide by mouth once a day for up to 7 weeks. Beginning 4 weeks later, patients will receive temozolomide by mouth on days 1-5. Treatment with temozolomide may repeat every 4 weeks for up to 12 courses. Beginning in week 4 of radiation therapy, patients will also receive a 30- to 90-minute infusion of bevacizumab every 2 weeks until finishing temozolomide.
After finishing treatment, patients will be evaluated every 3 months for 1 year, every 4 months for 1 year, and every 6 months thereafter.
Phase III Randomized Study of Memantine Hydrochloride in Preventing Cognitive Dysfunction in Patients Undergoing Whole-Brain Radiotherapy for Brain Metastases Secondary to Solid Tumors (RTOG 0614)
Purpose
Memantine may be able to decrease side effects caused by whole-brain radiation therapy. It is not yet known if memantine is effective in preventing side effects caused by whole-brain radiation therapy.
This randomized phase III trial is studying memantine to see how well it works compared to a placebo in preventing side effects caused by whole-brain radiation therapy in patients with brain metastases from solid tumors.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- At least 2 weeks but no more than 8 weeks since previous therapy for brain metastases, including radiosurgery or surgical resection
- More than 2 weeks since chemotherapy
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
- Patients in group one will undergo whole-brain radiation therapy 5 days a week for 3 weeks. They will also receive memantine by mouth once-a-day for 24 weeks starting on day 1 of radiation therapy.
- Patients in group two will undergo whole-brain radiation therapy 5 days-a-week for 3 weeks. They will also receive a placebo by mouth once-a-day for 24 weeks starting on day 1 of radiation therapy.
After finishing treatment, patients will be evaluated at 6 months, every 4 months for 1 year, every 6 months for 2 years, and once a year thereafter.