ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

This study is ongoing, but not recruiting participants.
Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Official Title  Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.

Detailed Description

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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Brain and Central Nervous System Tumors
Intervention  Drug: temozolomide
Procedure: radiation therapy
MEDLINE PMIDs 18082451,   17609661,   16735709,   16203762,   15758010,   15758009,   16321761,   15251162,   18213621,   16932504
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  July 2000
Completion Date
Eligibility 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

Gender Both
Ages 18 Years to 70 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Canada
Administrative Information Fields
NCT ID  NCT00006353
Organization ID CDR0000068220
Secondary IDs †† EORTC-26981, CAN-NCIC-CE3, EORTC-22981
Study Sponsor  European Organization for Research and Treatment of Cancer
Collaborators †† National Cancer Institute of Canada
Investigators 
Study Chair:     Roger Stupp, MD     Centre Hospitalier Universitaire Vaudois    
Study Chair:     Volker G. Budach, MD, PhD     Charite University, Berlin, Germany    
Study Chair:     J. Gregory Cairncross, MD     London Regional Cancer Program at London Health Sciences Centre    
Information Provided By National Cancer Institute (NCI)
Verification Date January 2008
First Received Date  October 4, 2000
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers