Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003688

Trial Description

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Title

A Randomized Phase III Study of Temozolomide and Short-Course Radiation Versus Short-Course Radiation Alone In The Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

OBJECTIVES:

Primary

- Compare overall survival rates in older patients with newly diagnosed glioblastoma
multiforme treated with short-course radiotherapy with or without temozolomide.

Secondary

- Compare progression-free survival of patients treated with these regimens.

- Compare the nature, severity, and frequency of adverse events in patients treated with
these regimens.

- Compare the quality of life of patient treated with these regimens.

- Determine the methylation status of the O6-methylguanine-DNA methyltransferase
promoter.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
center, age (65-70 years vs 71-75 years vs ≥ 76 years), ECOG performance status (0-1 vs 2),
and extent of resection at surgery (biopsy only vs complete or incomplete resection).
Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo radiotherapy once daily on days 1-5, 8-12, and 15-19 in the
absence of disease progression or unacceptable toxicity.

- Arm II: Patients undergo radiotherapy as in arm I and receive oral temozolomide once
daily on days 1-21.

Beginning 4 weeks after completion of radiotherapy and temozolomide, patients receive
adjuvant oral temozolomide once daily on days 1-5. Treatment with temozolomide alone repeats
every 28 days for up to 12 months in the absence of disease progression or unacceptable
toxicity.

Patients complete quality of life questionnaires at baseline and periodically during study
treatment.

Tissue samples are collected at baseline and analyzed for methylation status of the
O6-methylguanine-DNA methyltransferase promoter.

After completion of study treatment, patients are followed every 3 months.

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Organizational Data

  •   DRKS00003688
  •   2012/05/15
  •   2007/06/04
  •   yes
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Secondary IDs

  •   NCT00482677  (ClinicalTrials.gov)
  •   CE6  (NCIC Clinical Trials Group)
  •   CAN-NCIC-CE6 
  •   EORTC-26062-22061 
  •   TROG 08.02 
  •   SPRI-CAN-NCIC-CE.6 
  •   CDR0000547163 
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Health Condition or Problem studied

  •   Brain and Central Nervous System Tumors
  •   C71 -  Malignant neoplasm of brain
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Interventions/Observational Groups

  •   Drug: temozolomide
  •   Genetic: DNA methylation analysis
  •   Procedure: quality-of-life assessment
  •   Radiation: Radiation
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Overall survival; time frame: 7 years

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Secondary Outcome

- Progression-free survival; time frame: 7 years
- Adverse events; time frame: 7 years
- Quality of life; time frame: 7 years
- Methylation status of the O6-methylguanine-DNA methyltransferase promoter; time frame: 7 years

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Countries of Recruitment

  •   Canada
  •   Germany
  •   Japan
  •   Netherlands
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2007/05/31
  •   560
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   no maximum age
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Additional Inclusion 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

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Exclusion Criteria

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Addresses

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    • NCIC Clinical Trials Group
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    • European Organisation for Research and Treatment of Cancer - EORTC
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    • Trans-Tasman Radiation Oncology Group (TROG)
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    • Princess Margaret Hospital, Canada
    • Normand Laperriere, MD, FRCPC 
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    • Princess Margaret Hospital, Canada
    • Normand Laperriere, MD, FRCPC 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   8
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.