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Status:

COMPLETED

Radiation Therapy or Temozolomide in Treating Patients With Gliomas

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Collaborating Sponsors:

NCIC Clinical Trials Group

British Medical Research Council

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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 ...

Detailed Description

OBJECTIVES: Primary * Compare the progression-free survival of patients with low-grade gliomas treated with radiotherapy vs temozolomide. Secondary * Compare the overall survival of patients treat...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed low-grade glioma, including any of the following types:
  • Astrocytoma (gemistocytic, fibrillary, or protoplasmatic)
  • Oligoastrocytoma
  • Oligodendroglioma
  • WHO grade II disease
  • Supratentorial tumor location only
  • RTOG neurological function 0-3
  • Not a candidate for surgical treatment alone
  • Requires treatment, as determined by ≥ 1 of the following criteria:
  • Age ≥ 40 years
  • Radiologically-proven progressive lesion
  • New or worsening neurological symptoms other than seizures only (e.g., focal deficits, signs of increased intracranial pressure, or mental deficits)
  • Intractable seizures, defined by both of the following criteria:
  • Experiences persistent seizures that interfere with everyday life activities except driving a car
  • Failed 3 anti-epileptic drug regimens, including ≥ 1 combination regimen
  • Tumor material (paraffin-embedded) or histopathologic slides available
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • WHO 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • No chronic hepatitis B or C infection
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Other
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • No known HIV positivity
  • No other serious medical condition
  • No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No psychological, familial, sociological, or geographical condition that would preclude study participation
  • No medical condition that would preclude receiving oral medication (e.g., frequent vomiting or partial bowel obstruction)
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No concurrent growth factors for elevating absolute neutrophil counts for the purpose of temozolomide administration
  • No concurrent epoetin alfa
  • No concurrent immunotherapy or biologic therapy
  • Chemotherapy
  • No prior chemotherapy
  • No other concurrent chemotherapy, including adjuvant chemotherapy for patients randomized to undergo radiotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • No prior radiotherapy to the brain
  • No concurrent integrated boost with intensity-modulated radiotherapy
  • Surgery
  • Recovered from prior surgery
  • No concurrent surgical tumor debulking
  • Other
  • No prior randomization to this study
  • No other concurrent investigational drugs
  • No concurrent regular use of agents known to be radiosensitizers or radioprotectors (e.g., cyclooxygenase-2 inhibitors, thalidomide, or amifostine) during study radiotherapy
  • Occasional use of nonsteroidal anti-inflammatory drugs for pain allowed

Exclusion

    Key Trial Info

    Start Date :

    July 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2014

    Estimated Enrollment :

    709 Patients enrolled

    Trial Details

    Trial ID

    NCT00182819

    Start Date

    July 1 2005

    End Date

    May 1 2014

    Last Update

    October 12 2016

    Active Locations (89)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 23 (89 locations)

    1

    Prince of Wales Private Hospital

    Randwick, New South Wales, Australia, 2031

    2

    Royal North Shore Hospital

    St Leonards, New South Wales, Australia, 2065

    3

    Sydney Cancer Centre at Royal Prince Alfred Hospital

    Sydney, New South Wales, Australia, 2050

    4

    Calvary Mater Newcastle

    Waratah, New South Wales, Australia, 2298