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History of Changes for Study: NCT00182819
Radiation Therapy or Temozolomide in Treating Patients With Gliomas
Latest version (submitted October 11, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 15, 2005 None (earliest Version on record)
2 September 27, 2005 Study Status
3 October 5, 2005 Study Status
4 October 12, 2005 Eligibility, Study Description and Study Status
5 October 25, 2005 Contacts/Locations and Study Status
6 November 3, 2005 Study Status and Conditions
7 December 6, 2005 Study Status
8 January 10, 2006 Study Status
9 February 6, 2006 Study Status
10 March 8, 2006 Study Status
11 March 15, 2006 Study Status and Study Identification
12 April 5, 2006 Study Status
13 May 3, 2006 Study Status
14 May 23, 2006 Study Status
15 June 7, 2006 Study Status
16 June 28, 2006 Study Status
17 July 5, 2006 Study Status
18 July 13, 2006 Study Status
19 August 4, 2006 Study Status
20 August 16, 2006 Recruitment Status, Study Status and Contacts/Locations
21 November 8, 2006 Study Design, Conditions, Outcome Measures, Study Status and Study Identification
22 December 4, 2006 Study Status
23 December 20, 2006 Study Status and Contacts/Locations
24 January 11, 2007 Study Status
25 January 19, 2007 Contacts/Locations and Study Status
26 January 30, 2007 Eligibility, Study Description and Study Status
27 May 23, 2007 Study Status and Study Identification
28 July 10, 2007 Contacts/Locations and Study Status
29 August 6, 2007 Contacts/Locations and Study Status
30 September 7, 2007 Study Status
31 September 20, 2007 Contacts/Locations and Study Status
32 October 13, 2007 Study Status
33 October 25, 2007 Contacts/Locations and Study Status
34 December 6, 2007 Conditions and Study Status
35 December 8, 2007 Conditions and Study Status
36 December 19, 2007 Contacts/Locations and Study Status
37 December 25, 2007 Study Status
38 January 26, 2008 Contacts/Locations and Study Status
39 February 27, 2008 Contacts/Locations and Study Status
40 April 15, 2008 Study Status
41 April 30, 2008 Contacts/Locations and Study Status
42 May 23, 2008 Arms and Interventions and Study Status
43 July 23, 2008 Study Design and Study Status
44 November 20, 2008 Conditions and Study Status
45 January 7, 2009 Contacts/Locations and Study Status
46 February 6, 2009 Arms and Interventions and Study Status
47 June 16, 2009 Study Status
48 July 23, 2009 Study Status and Contacts/Locations
49 December 23, 2009 Sponsor/Collaborators and Study Status
50 April 2, 2010 Recruitment Status, Study Status and Contacts/Locations
51 April 14, 2010 References and Study Status
52 May 22, 2010 Recruitment Status, Study Status and Contacts/Locations
53 May 17, 2011 Recruitment Status, Study Status, Contacts/Locations and Study Identification
54 February 6, 2012 Study Identification, Outcome Measures, Arms and Interventions, Study Design, Contacts/Locations, Sponsor/Collaborators, Study Status and Oversight
55 December 2, 2014 Recruitment Status and Study Status
56 October 2, 2015 Study Status and References
57 October 11, 2016 Contacts/Locations and Study Status
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Study NCT00182819
Submitted Date:  September 15, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: CDR0000442397
Brief Title: Radiation Therapy or Temozolomide in Treating Patients With Gliomas
Official Title: Phase III Randomized Study of Radiotherapy Versus Temozolomide in Patients With Low-Grade Gliomas
Secondary IDs: EORTC-22033
EORTC-26033
EudraCT-2004-002714-11
CAN-NCIC-EORTC-22033
Open or close this module Study Status
Record Verification: September 2005
Overall Status: Not yet recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: September 15, 2005
First Submitted that
Met QC Criteria:
September 15, 2005
First Posted: September 16, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 15, 2005
Last Update Posted: September 16, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Responsible Party:
Collaborators: Canadian Cancer Trials Group
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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, chromosone 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 (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.

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.

Open or close this module Conditions
Conditions: Adult Oligodendroglioma
adult diffuse astrocytoma
Mixed Gliomas
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model:
Number of Arms:
Masking: (masked roles unspecified)
Enrollment:
Open or close this module Arms and Interventions
Intervention Details:
Drug: temozolomide
Procedure: chemotherapy
Procedure: radiation therapy
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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 funtion 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., cyclooxgenase-2 inhibitors, thalidomide, or amifostine) during study radiotherapy
  • Occasional use of nonsteriodal anti-inflammatory drugs for pain allowed
Open or close this module Contacts/Locations
Study Officials: Brigitta Baumert
Study Chair
UniversitaetsSpital
Roger Stupp, MD
Centre Hospitalier Universitaire Vaudois
Warren P. Mason, MD
Study Chair
Princess Margaret Hospital, Canada
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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