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Fluorescence-Guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid
This study has been completed.
Study NCT00241670   Information provided by medac GmbH
First Received: October 18, 2005   No Changes Posted

October 18, 2005
October 18, 2005
October 1999
 
  • 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).
  • 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).
Same as current
No Changes Posted
  • 1. Overall survival.
  • 2. Progression-free survival (PFS) 9, 12, 15 and 18 months after primary surgical treatment
  • 3. Volume of residual tumour
  • 4. Toxicity after oral administration of 5-Aminolevulinic acid.
  • 5. Neurological condition 7 days, 6 and 12 weeks, 6, 9, 12, and 18 months after primary surgical treatment
Same as current
 
Fluorescence-Guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid
Fluorescence-Guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) Vs. Conventional Resection

The 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.

Malignant gliomas are locally invasive tumors that carry a dismal prognosis despite a combination of surgery, radiotherapy and chemotherapy. Cytoreductive surgery is generally considered beneficial but complete resection of contrast enhancing tumor is achieved in less than 20 % of patients, one reason being the difficulty in discerning marginal, enhancing tumor intraoperatively.

Five-aminolevulinic acid (5-ALA) leads to the accumulation of fluorescent porphyrins in malignant gliomas, a phenomenon under exploration for intraoperative identification and resection of these tumors. This study investigated the benefit derived from fluorescent-guided resections using 5-ALA on surgical radicality, progression-free survival and morbidity.

Phase III
Interventional
Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
  • Brain Cancer
  • Brain Tumors
  • Cancer of Brain
  • Primary Brain Tumors
  • Brain Tumor, Primary
Drug: 5-aminolevulinic acid
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
270
 
 

Inclusion Criteria:

  • Radiological suspicion of a unilocular malignant glioma with distinct ring- or garland-shaped contrast agent-accumulating tumour structures and a core of reduced intensity in the MRI (central necroses) with no significant non-staining tumour tissue (exclusion of a secondary malignant glioma).
  • Indication for surgical tumour resection. If radical resection is planned, the location of the contrast agent-accumulating tumour should allow complete resection.
  • First operation of the tumour, no other tumour-specific pretreatment
  • Karnofsky at least 70 %
  • Patient’s written informed consent
  • Age 18-72 years

Exclusion Criteria:

  • Tumour location in the midline, basal ganglia, cerebellum or brain stem
  • More than one contrast agent-accumulating lesion unrelated to the primary tumour or extracerebral metastases
  • Porphyria, hypersensitivity to porphyrins
  • Renal insufficiency: Creatinine > 2.0 mg/dl
  • Hepatic insufficiency: Bilirubin > 3 mg/dl
  • Quick test < 60 %
  • gamma-GT > 70 U/I
  • Malignancies other than basaliomas
  • Existing or planned pregnancy or lactation, or inadequate contraception
  • Simultaneous participation in another clinical trial or participation in another clinical trial in the 30 days preceding randomisation
Both
18 Years to 72 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00241670
 
MC-ALS.3/GLI
medac GmbH
 
Study Chair: Hans-Juergen Reulen, MD Ludwig-Maximilians - University of Munich
medac GmbH
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP