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NCT00182819 · CITED IN SOURCE DOCUMENTS

Radiation Therapy or Temozolomide in Treating Patients With Gliomas

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2016-10-12

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. It is not yet known whether radiation therapy is more effective than temozolomide in treating gliomas. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Radiotherapy (control arm), 50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
    intervention Names
    1. Radiation: radiation therapy
    label
    radiotherapy
    type
    OTHER
  2. description
    Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles (experimental arm)
    intervention Names
    1. Drug: temozolomide
    label
    Temozolomide
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Temozolomide
    description
    Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles
    name
    temozolomide
    type
    DRUG
  2. arm Group Labels
    1. radiotherapy
    description
    50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
    name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
709
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Progression-free survival
    time Frame
    5 years
secondary Outcomes
  1. measure
    Overall survival
    time Frame
    5 years
  2. measure
    Quality of life as measured by QLQ-C30 v3.0 and EORTC BN-20
    time Frame
    every 3 months until progression, and then every 6 months until death
  3. measure
    Mini-Mental State Examination
    time Frame
    every 3 months until progression, and then every 6 months until death
  4. measure
    Adverse events as measured by CTCAE v3.0
    time Frame
    As indicated in the protocol
Full study description
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 the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective than temozolomide in treating gliomas. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas.
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 treated with these regimens. * Determine whether the incidence of late toxicity can be decreased in patients who are randomized to receive temozolomide. * Compare the toxic effects of these regimens in these patients. * Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center, chromosome 1p status (deleted vs normal vs undeterminable), contrast enhancement on MRI (yes vs no), age (\< 40 years vs ≥ 40 years), and WHO performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo radiotherapy once daily, 5 days a week, for a total of 28 fractions (i.e., 5½ weeks). * Arm II: Patients receive oral temozolomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 3 months until disease progression. After completion of study treatment, patients are followed every 6 months for survival. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A minimum of 699 patients (a total of 466 randomized \[233 per treatment arm\]) will be accrued for this study within 5 years.
Source references
references
  1. citation
    Musat E, Roelofs E, Bar-Deroma R, Fenton P, Gulyban A, Collette L, Stupp R, Weber DC, Bernard Davis J, Aird E, Baumert BG. Dummy run and conformity indices in the ongoing EORTC low-grade glioma trial 22033-26033: First evaluation of quality of radiotherapy planning. Radiother Oncol. 2010 May;95(2):218-24. doi: 10.1016/j.radonc.2010.03.005. Epub 2010 Apr 6.
    pmid
    20378192
    type
    BACKGROUND
  2. citation
    Fairchild A, Weber DC, Bar-Deroma R, Gulyban A, Fenton PA, Stupp R, Baumert BG. Quality assurance in the EORTC 22033-26033/CE5 phase III randomized trial for low grade glioma: the digital individual case review. Radiother Oncol. 2012 Jun;103(3):287-92. doi: 10.1016/j.radonc.2012.04.002. Epub 2012 May 3.
    pmid
    22560713
    type
    BACKGROUND
  3. citation
    Gao Y, Weenink B, van den Bent MJ, Erdem-Eraslan L, Kros JM, Sillevis Smitt P, Hoang-Xuan K, Brandes AA, Vos M, Dhermain F, Enting R, Ryan GF, Chinot O, Ben Hassel M, van Linde ME, Mason WP, Gijtenbeek JMM, Balana C, von Deimling A, Gorlia T, Stupp R, Hegi ME, Baumert BG, French PJ. Expression-based intrinsic glioma subtypes are prognostic in low-grade gliomas of the EORTC22033-26033 clinical trial. Eur J Cancer. 2018 May;94:168-178. doi: 10.1016/j.ejca.2018.02.023. Epub 2018 Mar 20.
    pmid
    29571083
    type
    DERIVED
  4. citation
    Baumert BG, Hegi ME, van den Bent MJ, von Deimling A, Gorlia T, Hoang-Xuan K, Brandes AA, Kantor G, Taphoorn MJB, Hassel MB, Hartmann C, Ryan G, Capper D, Kros JM, Kurscheid S, Wick W, Enting R, Reni M, Thiessen B, Dhermain F, Bromberg JE, Feuvret L, Reijneveld JC, Chinot O, Gijtenbeek JMM, Rossiter JP, Dif N, Balana C, Bravo-Marques J, Clement PM, Marosi C, Tzuk-Shina T, Nordal RA, Rees J, Lacombe D, Mason WP, Stupp R. Temozolomide chemotherapy versus radiotherapy in high-risk low-grade glioma (EORTC 22033-26033): a randomised, open-label, phase 3 intergroup study. Lancet Oncol. 2016 Nov;17(11):1521-1532. doi: 10.1016/S1470-2045(16)30313-8. Epub 2016 Sep 27.
    pmid
    27686946
    type
    DERIVED
  5. citation
    Reijneveld JC, Taphoorn MJB, Coens C, Bromberg JEC, Mason WP, Hoang-Xuan K, Ryan G, Hassel MB, Enting RH, Brandes AA, Wick A, Chinot O, Reni M, Kantor G, Thiessen B, Klein M, Verger E, Borchers C, Hau P, Back M, Smits A, Golfinopoulos V, Gorlia T, Bottomley A, Stupp R, Baumert BG. Health-related quality of life in patients with high-risk low-grade glioma (EORTC 22033-26033): a randomised, open-label, phase 3 intergroup study. Lancet Oncol. 2016 Nov;17(11):1533-1542. doi: 10.1016/S1470-2045(16)30305-9. Epub 2016 Sep 27.
    pmid
    27686943
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      1. context
        Updated: March 28, 2025
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        March 28, 2025

    Preserved source evidence · Not medical advice