NCT00002620

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for patients with anaplastic astrocytomas. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in treating patients with anaplastic astrocytomas.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
8 countries

14 active sites

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

November 1, 1994

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2000

Completed
4.1 years until next milestone

First Posted

Study publicly available on registry

July 19, 2004

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

5.6 years

First QC Date

November 1, 1999

Last Update Submit

June 29, 2012

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic astrocytoma

Interventions

carmustineDRUG
chemotherapyDRUG
mitolactolDRUG
low-LET cobalt-60 gamma ray therapyRADIATION
low-LET photon therapyRADIATION

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed anaplastic astrocytoma Standard maximum resection or stereotactic biopsy required within 4 weeks prior to therapy PATIENT CHARACTERISTICS: Age: Over 16 Performance status: ECOG/ZUBROD/WHO 0-2 Life expectancy: At least 8 weeks Hematopoietic: WBC greater than 4,000 Platelets greater than 100,000 Hematocrit greater than 30% Hepatic: Bilirubin less than 2 mg/dl Renal: Creatinine less than 1.5 mg/dl Creatinine clearance greater than 70 ml/min BUN less than 40 mg/dl Other: No major medical illness PRIOR CONCURRENT THERAPY: No anticancer drugs between surgery and protocol treatment No steroids after 10 days following surgery (may be resumed occasionally during radiotherapy)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (14)

Kaiser Franz Josef Hospital

Vienna (Wien), A-1100, Austria

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels (Bruxelles), 1090, Belgium

Location

Hopital Civil de Charleroi

Charleroi, 6000, Belgium

Location

Centre Hospitalier Regional de la Citadell

Liege (Luik), 4000, Belgium

Location

Neurologische Klinik der Henriettenstiftung

Hanover, D-30559, Germany

Location

Regional Hospital Treviso

Treviso, 31100, Italy

Location

Rotterdam Cancer Institute

Rotterdam, 3075 EA, Netherlands

Location

Dr. Bernard Verbeeten Instituut

Tilburg, 5042 SB, Netherlands

Location

Academisch Ziekenhuis Utrecht

Utrecht, 3508 GA, Netherlands

Location

Instituto Portugues de Oncologia de Francisco Gentil

Lisbon, 1093, Portugal

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Related Publications (2)

  • Hildebrand J, Gorlia T, Kros JM, Afra D, Frenay M, Omuro A, Stupp R, Lacombe D, Allgeier A, van den Bent MJ; EORTC Brain Tumour Group investigators. Adjuvant dibromodulcitol and BCNU chemotherapy in anaplastic astrocytoma: results of a randomised European Organisation for Research and Treatment of Cancer phase III study (EORTC study 26882). Eur J Cancer. 2008 Jun;44(9):1210-6. doi: 10.1016/j.ejca.2007.12.005. Epub 2008 Jan 14.

    PMID: 18248979RESULT

  • Hildebrand J, Sahmoud T, Mignolet F, Brucher JM, Afra D. Adjuvant therapy with dibromodulcitol and BCNU increases survival of adults with malignant gliomas. EORTC Brain Tumor Group. Neurology. 1994 Aug;44(8):1479-83. doi: 10.1212/wnl.44.8.1479.

    PMID: 8058153RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsAstrocytoma

Interventions

CarmustineDrug TherapyMitolactol

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsTherapeuticsGalactitolSugar AlcoholsAlcoholsCarbohydrates

Study Officials

  • J. Hildebrand, MD

    Erasme University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 19, 2004

Study Start

November 1, 1994

Primary Completion

June 1, 2000

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

IT(1)DE(1)BE(4)AU(1)NL(3)PT(1)CH(1)GB(2)