Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma

Conditions

• Glioblastoma
• Gliosarcoma
• Supratentorial Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 3-Dimensional Conformal Radiation Therapy — RADIATION
  Undergo 3-dimentional conformal radiation therapy
• Bevacizumab — BIOLOGICAL
  Given IV
• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo intensity-modulated radiation therapy
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Placebo — OTHER
  Given IV
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Temozolomide — DRUG
  Given orally

Study Details

This randomized phase III trial studies temozolomide (TMZ) and radiation therapy (RT) to compare how well they work with or without bevacizumab in treating patients with newly diagnosed glioblastoma or gliosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may find tumor cells and help kill 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.

Key Dates

First listed

Apr 21, 2009

Start date

Apr 15, 2009

Status verified

Jul 2019

Primary completion

Mar 17, 2013

Completion

Mar 17, 2013

Study Design

Enrollment

637 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (radiation therapy, temozolomide, placebo)
  Patients undergo intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy 5 days a week for 6 weeks and receive temozolomide PO QD for up to 7 weeks. Beginning 4 weeks after completion of chemotherapy and radiation therapy, patients receive temozolomide PO QD on days 1-5. Treatment with temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive placebo IV over 30-90 minutes once every 2 weeks beginning in week 4 of chemotherapy and radiation therapy and continuing until the completion of temozolomide.
• Experimental: Arm II (radiation therapy, temozolomide, bevacizumab)
  Patients undergo radiation therapy and receive temozolomide as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning in week 4 of chemoradiotherapy and continuing until the completion of adjuvant temozolomide.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported. ]

Locations (324)

Find similar trials in Mobile, AL

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