Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
18 Years
70 Years
Both
Brain and Central Nervous System Tumors
Trial Information
Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
OBJECTIVES: I. Compare the efficacy of radiotherapy with or without temozolomide in terms of
overall survival in patients with newly diagnosed glioblastoma multiforme. II. Compare the
toxicity profiles of these regimens in these patients. III. Compare the progression free
survival of these patients treated with these regimens. IV. Compare the quality of life in
these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, age (under 50 vs 50 and over), WHO/ECOG performance status (0-1 vs 2),
and extent of surgical resection (biopsy only vs complete or incomplete resection). Patients
are randomized to one of two treatment arms. Arm I: Patients undergo radiotherapy 5 days a
week for 6 weeks. Arm II: Patients undergo radiotherapy as in arm I concurrently with oral
temozolomide daily for 6 weeks. Patients then receive adjuvant oral temozolomide alone on
days 1-5 every 28 days for 6 courses beginning 4 weeks after completion of radiotherapy.
Quality of life is assessed prior to the study, at week 4 during radiotherapy, at 4 weeks
after completion of radiotherapy, at the end of courses 3 and 6 of adjuvant chemotherapy
(arm II), and then every 3 months until disease progression. Patients are followed every 3
months until disease progression or death.
PROJECTED ACCRUAL: A total of 520 patients (260 per treatment arm) will be accrued for this
study within 3.5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed glioblastoma multiforme
by biopsy or surgical resection Grade IV disease Initial diagnosis no greater than 6 weeks
prior to study
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST or ALT less than 2.5 times ULN Alkaline phosphatase less than 2.5 times ULN No chronic
hepatitis B or C Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception No known
HIV infection No medical condition that would interfere with oral medication intake (e.g.,
frequent vomiting or partial bowel obstruction) No other prior or concurrent malignancy
except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer No
serious medical, psychological, familial, sociological, or geographical condition that
would preclude study
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim (G-CSF), sargramostim
(GM-CSF), or epoetin alfa No concurrent biologic therapy No concurrent immunotherapy
Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: At
least 14 days of prior corticosteroids at a stable dose required Concurrent
corticosteroids allowed Radiotherapy: No prior radiotherapy No concurrent stereotactic
boost radiotherapy Surgery: See Disease Characteristics No concurrent surgery for tumor
debulking Other: No other concurrent investigational drugs
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Roger Stupp, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Hospitalier Universitaire Vaudois
Authority:
United States: Federal Government
Study ID:
EORTC-26981-22981
NCT ID:
NCT00006353
Start Date:
July 2000
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
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