NCT00241670|CompletedPhase 3
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Sponsor study identifier
interventional
415
0 countries
N/A
Study Start
October 1999
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2004
Actual (reported)Study Completion
Not reported
Date not reportedThe aim of the study "Fluorescence-guided resection of malignant gliomas with 5-Aminolevulinic acid (5-ALA) vs. conventional resection" is to determine how accurately contrast agent-accumulating tumour can be removed by primary surgery and to assess the clinical usefulness of this method.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1999
Date type not reportedThis date has not been verified as actual or estimated.
July 2004
Actual (reported)October 18, 2005
Actual (reported)October 19, 2005
Actual (reported)1. Percentage of patients with a histologically confirmed malignant glioma (grade III or IV -WHO) without definite residual contrast agent-accumulating tumour in the early post-operative control MRI (within 72 hours of the operation).
Within 72 hours after surgery
2. Progression-free survival 6 months after primary surgical treatment of a malignant gli-oma in patients with histologically confirmed malignant glioma (grade III or IV -WHO).
Within 6 month after surgery
1. Overall survival.
Until 18 months after surgery
1.5 grams 5-ALA dissolved in 50 ml water, single dose, orally, 2-4 hours prior to surgery
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.
Hans-Juergen Reulen, MD
Ludwig-Maximilians - University of Munich
415 participants (actual enrollment reported by the registry).
First Submitted
October 18, 2005
First Posted
October 19, 2005
Study Start
October 1999
Date type not reportedThis date has not been verified as actual or estimated.
2. Progression-free survival (PFS) 9, 12, 15 and 18 months after primary surgical treatment
Until 18 months after surgery
3. Volume of residual tumour
After surgery
4. Toxicity after oral administration of 5-Aminolevulinic acid.
Until 18 month after surgery
5. Neurological condition 7 days, 6 and 12 weeks, 6, 9, 12, and 18 months after primary surgical treatment
Until 18 month after surgery
Contact the study team to confirm eligibility.
Primary Completion
July 2004
Actual (reported)Last Updated
April 26, 2012
Record last verified: 2012-04
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Source: ClinicalTrials.gov.
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