Purpose
Standard
Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With
Glioma
This study
is currently recruiting patients.
Sponsored by
EORTC Radiotherapy
Cooperative Group
Purpose
RATIONALE: Radiation therapy uses
high-energy x-rays to damage tumor cells and may be an effective treatment for patients
with glioma. Stereotactic radiation therapy may be able to deliver x-rays directly to the
tumor and cause less damage to normal tissue. It is not yet known if standard radiation
therapy is more effective when followed by stereotactic radiation therapy. PURPOSE:
Randomized phase III trial to compare the effectiveness of standard radiation therapy with
or without stereotactic radiation therapy in treating patients who have glioma.
Condition
|
Phase |
adult
glioblastoma multiforme adult anaplastic astrocytoma quality of life |
Phase
III |
Study Type: Treatment
Official Title: Phase III Randomized Study of Adjuvant
Conventional Radiotherapy With or Without Stereotactic Boost Radiotherapy in Patients with
High Grade Glioma
Further Study Details: OBJECTIVES: I. Compare the effect of
adjuvant conventional radiotherapy with or without fractionated stereotactic boost
radiotherapy on survival in patients with high grade glioma. II. Compare the quality of
life of these patients after these therapies. PROTOCOL OUTLINE: This is a randomized
study. Patients are stratified according to WHO disease grade (III vs IV), center, and age
(under 40 vs 40 and over). Patients are randomized to undergo stereotactic radiotherapy or
no further treatment after conventional radiotherapy. Patients undergo conventional
radiotherapy once or twice a day for up to 6 weeks. Patients randomized to receive
additional treatment receive stereotactically guided conformal boost radiotherapy for 4
days, within 4 weeks after completion of conventional radiotherapy. Quality of life is
assessed before radiotherapy, then at follow up visits. Patients are followed every 3
months for 1 year, every 6 months for 1 year, then annually thereafter. PROJECTED
ACCRUAL: A total of 605 patients will be accrued for this study.
Eligibility
Ages Eligible for Study: 18 Years
- 65 Years Criteria
PROTOCOL ENTRY CRITERIA: --Disease
Characteristics-- Histologically proven WHO grade III or IV glioma at primary diagnosis
that enhance on preoperative imaging Glioblastoma Anaplastic astrocytoma Gliosarcoma Tumor
volume no greater than 4.0 cm in maximum diameter on preoperative CT or MRI No prior
histology of WHO grade I or II glioma Astrocytoma Oligodendroglioma No brainstem or
infratentorial tumor No multifocal glioma Safe to treat tumor stereotactically No close
proximity to critical structures, e.g., optic chiasm --Prior/Concurrent Therapy-- Biologic
therapy: Not specified Chemotherapy: No prior chemotherapy No concurrent adjuvant
chemotherapy Endocrine therapy: Concurrent steroids allowed Radiotherapy: See Disease
Characteristics No prior radiotherapy to the head and neck area No prior radiotherapy to
the brain Surgery: See Disease Characteristics No more than 6 weeks since prior
neurosurgery --Patient Characteristics-- Age: 18 to 65 Performance status: WHO 0 or 1 Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: Able to tolerate full course of conventional radiotherapy No prior or
concurrent medical condition to preclude study therapy No prior malignancies within 5
years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
Location and Contact Information
Denmark
Rigshospitalet, Copenhagen,
2100, Denmark; Recruiting
Hans Skougaarp Poulsen
+45-35-45-48-54
France
Centre Jean Perrin, Clermont-Ferrand,
63011, France; Recruiting
P. Verrelle
73-27-80-80
France
CHR de Grenoble - La
Tronche, Grenoble, 38043, France; Recruiting
Michel Bolla
33 476765506
France
Hopital Jules Courmont - Centre Hospitalier
Lyon Sud, Pierre Benite, 69495, France; Recruiting
Jean Pierre Gerard
04-78-86-11-57
France
Institut Bergonie, Bordeaux,
33076, France; Recruiting
G. Kantor
05-56-33-33-33
Germany
Clemenshospital, Munster (Muenster),
D-48153, Germany; Recruiting
A.R. Fischedick
Germany
Klinik Und Poliklinik Fur
Strahlentherapie, Erlangen, DOH-9-1054,
Germany; Recruiting
Rolf Sauer
09131-85-3404
Germany
Klinikum Rechts Der Isar/Technische
Universitaet Muenchen, Munich (Muenchen), D-81675,
Germany; Recruiting
M. Moll 089
4140 4501
Germany
Krankenhaus Neukoelln, Berlin,
D-12313, Germany; Recruiting
J. Zierski 030
6004 2041
Germany
Medizinische Klinik I, Dresden,
D-01307, Germany; Recruiting
H. Alheit 0351
458 3373
Germany
Otto-Von-Guericke-Universitaet
Magdeburg, Magdeburg, D-39120, Germany; Recruiting
Gunther F. Gademann
0391-6715791
Germany
Radiologische
Universitatsklinik, Tubingen, D-72076,
Germany; Recruiting
G. Becker
Germany
Universitaet
Wuerzburg/Hautkrankheiten, Wuerzburg, D-97080,
Germany; Recruiting
Michael P. Flentje
0931-2015350
Germany
Universitaetsklinikum Charite, Berlin,
D-10117, Germany; Recruiting
R. Wurm
49-30-2802-2228
Israel
Rambam Medical Center, Haifa,
31096, Israel; Recruiting
Abraham Kuten
972-4-8543003
Italy
Department of Radiotherapy, Naples
(Napoli), 80123, Italy; Recruiting
Paolo Muto
081-7145955
Italy
Istituto Nazionale per lo Studio e la Cura
dei Tumori, Milano (Milan), 20133, Italy; Recruiting
A. Gramaglia
39-2-2390-761
Italy
Ospedale St. Santa Chiara, Pisa,
56100, Italy; Recruiting
Luca Cionini
39-50-992540
Netherlands
Medisch Centrum
Haaglanden, 's-Gravenhage (Den Haag, The Hague), 2501 CK,
Netherlands; Recruiting
Charles Niel
070-3302000
Netherlands
Rotterdam Cancer Institute, Rotterdam,
3075 EA, Netherlands; Recruiting
Peter C. Levendag
011-31-10-4391366
Spain
Hospital San Fransisco de
Asis, Madrid, 28002, Spain; Recruiting
M. Santos 34
91 5643060
Spain
Institut Catala d'Oncologia - Hospital
Duran i Reynals, Barcelona, 08907, Spain; Recruiting
Salvador Villa
349-320-7722
Spain
Instituto Valenciano De
Oncologia, Valencia, 46009, Spain; Recruiting
Jose Lopez Torrecilla
963862977
Sweden
Umea Universitet, Umea,
S-901 85, Sweden; Recruiting
Roger Henriksson
46 90 7852917
Switzerland
Centre Hospitalier Universitaire
Vaudois, Lausanne, CH-1011, Switzerland; Recruiting
Philippe Coucke
+41-21-314'46'00
Switzerland
Division of Radiation
Oncology, Geneva, 1211, Switzerland; Recruiting
Raymond Miralbell
4122-382-70-98
Switzerland
Ospedale San Giovanni, Bellinzona,
CH-6500, Switzerland; Recruiting
Jacques Bernier
41-91-820-91-57
Switzerland
Universitaetsspital, Zurich,
CH-8091, Switzerland; Recruiting
Brigitta Baumert
41-7-255-2930
England, United Kingdom
Nottingham City Hospital NHS
Trust, Nottingham, England, NG5 1PB, United
Kingdom; Recruiting
M. Sokal 115
9691169 ext.47300
England, United Kingdom
Royal Marsden Hospital, Sutton,
England, SM2 5PT, United Kingdom; Recruiting
Michael Brada
44-208-6426011 ext. 3272
Scotland, United Kingdom
Western General Hospital, Edinburgh,
Scotland, EH4 9NQ, United Kingdom; Recruiting
Anna Gregor
00-44-131-5373051
Study chairs or principal investigators
Brigitta Baumert, Study Chair
EORTC Radiotherapy Cooperative Group
More Information
Study ID Numbers 199/14295;
EORTC-22972; EORTC-26991; MRC-BR10
NLM Identifier NCT00003916
Date study started April 30, 1999