Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00003916




Registration number
NCT00003916
Ethics application status
Date submitted
1/11/1999
Date registered
16/02/2004
Date last updated
24/09/2012

Titles & IDs
Public title
Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma
Scientific title
Focal Fractionated Conformal Stereotactic Boost Following Conventional Radiotherapy of High Grade Gliomas: A Randomized Phase III Study
Secondary ID [1] 0 0
EORTC-22972
Secondary ID [2] 0 0
EORTC-22972-26991
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain and Central Nervous System Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion 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

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 that would preclude study therapy No prior malignancies within 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix

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 No more than 6 weeks since other prior radiotherapy Surgery: See Disease Characteristics
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Nice
Country [2] 0 0
Germany
State/province [2] 0 0
Dresden
Country [3] 0 0
Germany
State/province [3] 0 0
Wuerzburg
Country [4] 0 0
Netherlands
State/province [4] 0 0
Amsterdam
Country [5] 0 0
Spain
State/province [5] 0 0
Barcelona
Country [6] 0 0
Switzerland
State/province [6] 0 0
Zurich
Country [7] 0 0
United Kingdom
State/province [7] 0 0
England

Funding & Sponsors
Primary sponsor type
Other
Name
European Organisation for Research and Treatment of Cancer - EORTC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brigitta Baumert, MD, PhD
Address 0 0
UniversitaetsSpital Zuerich
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT00003916