NCT00241670

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
415

participants targeted

Target at P50-P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2005

Completed
Last Updated

April 26, 2012

Status Verified

April 1, 2012

Enrollment Period

4.8 years

First QC Date

October 18, 2005

Last Update Submit

April 25, 2012

Conditions

Brain CancerBrain TumorsCancer of BrainPrimary Brain TumorsBrain Tumor, Primary

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (5)

  • 1. Overall survival.

    Until 18 months after surgery

  • 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

Study Arms (2)

5-aminolevulinic acid

EXPERIMENTAL
Drug: 5-aminolevulinic acid (5-ALA)

Conventional resection

NO INTERVENTION

Interventions

5-aminolevulinic acid (5-ALA)DRUG

1.5 grams 5-ALA dissolved in 50 ml water, single dose, orally, 2-4 hours prior to surgery

5-aminolevulinic acid

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 16648043DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Levulinic AcidsKeto AcidsCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Hans-Juergen Reulen, MD

    Ludwig-Maximilians - University of Munich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2005

First Posted

October 19, 2005

Study Start

October 1, 1999

Primary Completion

July 1, 2004

Last Updated

April 26, 2012

Record last verified: 2012-04