Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: temozolomide; DNA methylation analysis; quality-of-life assessment; Radiation
Intervention description: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.; A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms; prior to randomization until end of study; Short course radiotherapy
Intervention MeSH terms: Temozolomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 562.0
Sex: All
Minimum age: 65 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adult glioblastoma; adult giant cell glioblastoma; adult 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 whether radiation
      therapy and temozolomide are more effective than radiation therapy alone in treating
      glioblastoma multiforme.

      PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to
      see how well they work compared with radiation therapy alone in treating patients with newly
      diagnosed glioblastoma multiforme.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histopathologically confirmed glioblastoma multiforme

               -  Grade IV disease by WHO classification

               -  Newly diagnosed disease

          -  Initial diagnostic surgery or biopsy performed within the past 4 weeks

          -  Not a candidate for standard radiotherapy (60Gy/30 fractions over 6 weeks) in
             combination with temozolomide

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Absolute granulocyte count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Creatinine ≤ 1.5 times upper limit of normal (ULN)

          -  Bilirubin ≤ 1.5 times ULN

          -  ALT and AST < 2.5 times ULN

          -  No known hypersensitivity to temozolomide or compounds with similar chemical
             composition to temozolomide

          -  No history of other malignancies except adequately treated nonmelanoma skin cancer,
             curatively treated in situ cancer of the cervix, or other curatively treated solid
             tumors with no evidence of disease for at least 5 years

          -  No serious active infection (e.g., wound infection requiring parenteral antibiotics)
             or other serious underlying medical conditions that would preclude study treatment

          -  No other condition (e.g., psychological or geographical) that would preclude study
             compliance

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy

          -  No prior radiotherapy

          -  No prior or concurrent investigational therapy

          -  No concurrent surgical procedures for tumor debulking

          -  No concurrent stereotactic boost radiotherapy

          -  No other concurrent chemotherapy, immunotherapy, or biological therapy

          -  No concurrent epoetin alfa

          -  Concurrent corticosteroids allowed provided the patient has been on a stable or
             decreasing dose for at least 14 days