Skip to content
Triangle logo TriangleGet started
← Study library

NCT00002840 · CITED IN SOURCE DOCUMENTS

Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma

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
2012-07-10

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, and may be an effective treatment for anaplastic oligodendroglioma. Combining combination chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare radiation therapy with and without combination chemotherapy in patients with resected anaplastic oligodendroglioma.

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: Newly diagnosed oligodendroglioma or oligoastrocytoma (with at least 25% oligodendral elements) Low-grade oligodendroastrocytoma or oligodendroglioma that is recurrent after surgery without radiotherapy is allowed Prior partial or gross total resection of tumor (or biopsy only in case of no further surgical option) required At least 3 of the following histologic anaplastic features: High cellularity Endothelial abnormalities Nuclear abnormalities Necrosis Mitoses PATIENT CHARACTERISTICS: Age: 16 to 69 Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.4 mg/dL Renal: Creatinine no greater than 1.3 mg/dL Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception No active or uncontrolled infection No other disease, including malignancy, that would preclude study No neurologic or psychiatric disturbance that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to the skull Surgery: See Disease Characteristics
healthy Volunteers
false
maximum Age
69 Years
minimum Age
16 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    lomustine
    type
    DRUG
  2. name
    procarbazine hydrochloride
    type
    DRUG
  3. name
    vincristine sulfate
    type
    DRUG
  4. name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
primary Purpose
TREATMENT
Enrollment
count
350
type
ESTIMATED
Registered outcome plans (not posted results)
Full study description
brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, and may be an effective treatment for anaplastic oligodendroglioma. Combining combination chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare radiation therapy with and without combination chemotherapy in patients with resected anaplastic oligodendroglioma.
detailed Description
OBJECTIVES: I. Compare survival and time to first progression in patients with anaplastic oligodendroglioma treated with radiotherapy with or without adjuvant procarbazine, lomustine, and vincristine (PCV) following surgical resection. II. Investigate the effect of PCV on quality of life and neurologic function in these patients. III. Determine the toxicity of PCV in these patients. IV. Correlate chromosomal lesions (1p and/or 19q, 9p, p53 loss and mutation, amplification of chromosome 7, or loss of chromosome 10) with progression-free and overall survival in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age, extent of resection, performance status, prior surgery, and participating center. Patients are randomized to one of two treatment arms. Arm I: Within 4-6 weeks after surgery, patients undergo radiotherapy over 7 weeks to the residual tumor volume. Arm II: Patients undergo radiotherapy as in arm I, then begin chemotherapy within 4 weeks after the completion of radiotherapy. Patients receive oral lomustine on day 1, oral procarbazine on days 8-21, and vincristine IV on days 8 and 29. Treatment repeats every 6 weeks in stable and responding patients for a total of 6 courses. Patients with disease recurrence may receive 6 additional courses of chemotherapy as above or another modality at the investigator's discretion. Patients are followed every 3 months for 1 year and then every 6 months for survival. PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 4 years.
Source references
references
  1. citation
    Idbaih A, Dalmasso C, Kouwenhoven M, Jeuken J, Carpentier C, Gorlia T, Kros JM, French P, Teepen J, Broet P, Delattre O, Mokhtari K, Sanson M, Delattre JY, van den Bent M, Hoang-Xuan K. Genomic aberrations associated with outcome in anaplastic oligodendroglial tumors treated within the EORTC phase III trial 26951. J Neurooncol. 2011 Jun;103(2):221-30. doi: 10.1007/s11060-010-0380-9. Epub 2010 Sep 6.
    pmid
    20820870
    type
    RESULT
  2. citation
    Mokhtari K, Ducray F, Kros JM, Gorlia T, Idbaih A, Taphoorn M, Wesseling P, Hoang-Xuan K, Van den Bent M, Sanson M. Alpha-internexin expression predicts outcome in anaplastic oligodendroglial tumors and may positively impact the efficacy of chemotherapy: European organization for research and treatment of cancer trial 26951. Cancer. 2011 Jul 1;117(13):3014-26. doi: 10.1002/cncr.25827. Epub 2011 Jan 18.
    pmid
    21246521
    type
    RESULT
  3. citation
    van den Bent MJ, Gravendeel LA, Gorlia T, Kros JM, Lapre L, Wesseling P, Teepen JL, Idbaih A, Sanson M, Smitt PA, French PJ. A hypermethylated phenotype is a better predictor of survival than MGMT methylation in anaplastic oligodendroglial brain tumors: a report from EORTC study 26951. Clin Cancer Res. 2011 Nov 15;17(22):7148-55. doi: 10.1158/1078-0432.CCR-11-1274. Epub 2011 Sep 13.
    pmid
    21914791
    type
    RESULT
  4. citation
    Preusser M, Hoeftberger R, Woehrer A, et al.: Prognostic value and analytical performance (reproducibility) of Ki67 index in anaplastic oligodendroglial tumors: A translational study of the EORTC Brain Tumor Group. [Abstract] J Clin Oncol 28 (Suppl 15): A-2029, 2010.
    type
    RESULT
  5. citation
    van den Bent MJ, Dubbink HJ, Marie Y, Brandes AA, Taphoorn MJ, Wesseling P, Frenay M, Tijssen CC, Lacombe D, Idbaih A, van Marion R, Kros JM, Dinjens WN, Gorlia T, Sanson M. IDH1 and IDH2 mutations are prognostic but not predictive for outcome in anaplastic oligodendroglial tumors: a report of the European Organization for Research and Treatment of Cancer Brain Tumor Group. Clin Cancer Res. 2010 Mar 1;16(5):1597-604. doi: 10.1158/1078-0432.CCR-09-2902. Epub 2010 Feb 16.
    pmid
    20160062
    type
    RESULT
  6. citation
    Kouwenhoven MC, Gorlia T, Kros JM, Ibdaih A, Brandes AA, Bromberg JE, Mokhtari K, van Duinen SG, Teepen JL, Wesseling P, Vandenbos F, Grisold W, Sipos L, Mirimanoff R, Vecht CJ, Allgeier A, Lacombe D, van den Bent MJ. Molecular analysis of anaplastic oligodendroglial tumors in a prospective randomized study: A report from EORTC study 26951. Neuro Oncol. 2009 Dec;11(6):737-46. doi: 10.1215/15228517-2009-011.
    pmid
    19224764
    type
    RESULT
  7. citation
    van den Bent MJ, Dubbink HJ, Sanson M, van der Lee-Haarloo CR, Hegi M, Jeuken JW, Ibdaih A, Brandes AA, Taphoorn MJ, Frenay M, Lacombe D, Gorlia T, Dinjens WN, Kros JM. MGMT promoter methylation is prognostic but not predictive for outcome to adjuvant PCV chemotherapy in anaplastic oligodendroglial tumors: a report from EORTC Brain Tumor Group Study 26951. J Clin Oncol. 2009 Dec 10;27(35):5881-6. doi: 10.1200/JCO.2009.24.1034. Epub 2009 Nov 9.
    pmid
    19901104
    type
    RESULT
  8. citation
    Kros JM, Gorlia T, Kouwenhoven MC, Zheng PP, Collins VP, Figarella-Branger D, Giangaspero F, Giannini C, Mokhtari K, Mork SJ, Paetau A, Reifenberger G, van den Bent MJ. Panel review of anaplastic oligodendroglioma from European Organization For Research and Treatment of Cancer Trial 26951: assessment of consensus in diagnosis, influence of 1p/19q loss, and correlations with outcome. J Neuropathol Exp Neurol. 2007 Jun;66(6):545-51. doi: 10.1097/01.jnen.0000263869.84188.72.
    pmid
    17549014
    type
    RESULT
  9. citation
    Mauer ME, Taphoorn MJ, Bottomley A, Coens C, Efficace F, Sanson M, Brandes AA, van der Rijt CC, Bernsen HJ, Frenay M, Tijssen CC, Lacombe D, van den Bent MJ; EORTC Brain Cancer Group. Prognostic value of health-related quality-of-life data in predicting survival in patients with anaplastic oligodendrogliomas, from a phase III EORTC brain cancer group study. J Clin Oncol. 2007 Dec 20;25(36):5731-7. doi: 10.1200/JCO.2007.11.1476.
    pmid
    18089867
    type
    RESULT
  10. citation
    Taphoorn MJ, van den Bent MJ, Mauer ME, Coens C, Delattre JY, Brandes AA, Sillevis Smitt PA, Bernsen HJ, Frenay M, Tijssen CC, Lacombe D, Allgeier A, Bottomley A; European Organisation for Research and Treatment of Cancer. Health-related quality of life in patients treated for anaplastic oligodendroglioma with adjuvant chemotherapy: results of a European Organisation for Research and Treatment of Cancer randomized clinical trial. J Clin Oncol. 2007 Dec 20;25(36):5723-30. doi: 10.1200/JCO.2007.12.7514.
    pmid
    18089866
    type
    RESULT
  11. citation
    van den Bent MJ, Carpentier AF, Brandes AA, Sanson M, Taphoorn MJ, Bernsen HJ, Frenay M, Tijssen CC, Grisold W, Sipos L, Haaxma-Reiche H, Kros JM, van Kouwenhoven MC, Vecht CJ, Allgeier A, Lacombe D, Gorlia T. Adjuvant procarbazine, lomustine, and vincristine improves progression-free survival but not overall survival in newly diagnosed anaplastic oligodendrogliomas and oligoastrocytomas: a randomized European Organisation for Research and Treatment of Cancer phase III trial. J Clin Oncol. 2006 Jun 20;24(18):2715-22. doi: 10.1200/JCO.2005.04.6078.
    pmid
    16782911
    type
    RESULT
  12. citation
    van den Bent MJ, Delattre JY, Brandes AA, et al.: First analysis of EORTC trial 26951, a randomized phase III study of adjuvant PCV chemotherapy in patients with highly anaplastic oligodendroglioma. [Abstract] J Clin Oncol 23 (Suppl 16): A-1503, 114s, 2005.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-5a6cd63a2a1d41a92dd4
      requested nct id
      NCT00002840
      primary nct id
      NCT00002840
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      00198fe0f12adc95541ac85332c2ad520be3a395e64c0725a029ea5082d743e5
      payload sha256
      cba9cacbe705b0f2e52d653e27d76c5dad16b30eed83d750a6a08ec271cafcd2
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-5a6cd63a2a1d41a92dd4
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00002840
      occurrences
      1. context exact
        tion therapy with or without chemotherapy):</p> <div class="pdq-content-list"><ol id="_1293"><li>Mature results from the EORTC <a href="/clinicaltrials/NCT00002840">Brain Tumor Group Study 26951</a> (NCT00002840), a phase III randomized study with 11.7 years of follow-up, demonstrated increased OS and PFS in patients wi
        end
        138493
        exact text
        NCT00002840
        start
        138482
      2. context exact
        <div class="pdq-content-list"><ol id="_1293"><li>Mature results from the EORTC <a href="/clinicaltrials/NCT00002840">Brain Tumor Group Study 26951</a> (NCT00002840), a phase III randomized study with 11.7 years of follow-up, demonstrated increased OS and PFS in patients with anaplastic oligodendroglial tumors with six c
        end
        138541
        exact text
        NCT00002840
        start
        138530
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/865e7a313be74281ba.html
      source file sha256
      00198fe0f12adc95541ac85332c2ad520be3a395e64c0725a029ea5082d743e5
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:21:31.446649+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      313573c355641616d4b5e97efef760e3f0ef1d7281e3b5c825af29ea09137135
      source title
      Central Nervous System Tumors Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: March 28, 2025
        datetime
        2025-03-28T12:00:00Z
        display
        March 28, 2025

    Preserved source evidence · Not medical advice