Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known which schedule of temozolomide when given together with radiation therapy is more effective in treating glioblastoma or gliosarcoma.

PURPOSE: This randomized phase III trial is studying two different schedules of temozolomide to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed glioblastoma or gliosarcoma.

Conditions

• Brain and Central Nervous System Tumors

Interventions

DRUG

Concurrent temozolomide

Daily oral temozolomide (75 mg/m2) up to 49 doses.

RADIATION

Concurrent radiation therapy

60 Gy in 2 Gy fractions

DRUG

100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle

Oral temozolomide on days 1-5 of a 28-day cycle. Dose starts at 150mg/m2 for first cycle, increases to 200mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.

DRUG

75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle

Oral temozolomide on days 1-21 of a 28-day cycle. Dose starts at 75mg/m2 for first cycle, increases to 100mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• European Organisation for Research and Treatment of Cancer - EORTC

  collaborator NETWORK

• NRG Oncology

  collaborator OTHER

• Radiation Therapy Oncology Group

  lead NETWORK

Principal Investigators

• Mark R. Gilbert, MD · M.D. Anderson Cancer Center

• Minesh P. Mehta, MD · University of Wisconsin, Madison

• Roger Stupp, MD · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-01-31

Primary Completion

2011-02-28

Completion

2016-12-31

Countries

• United States
• Canada

Study Locations