Brain and Central Nervous System TumorsPhase 3NCT00003916
Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma
A Phase 3 study testing radiation therapy and stereotactic radiosurgery in people with Brain and Central Nervous System Tumors, run by European Organisation for Research and Treatment of Cancer - EORTC at 8 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- radiation therapy and stereotactic radiosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 8 sitesin 7 countries
- Study dates
- Apr 1999to Dec 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Germany2 sites
Medizinische Klinik I
Dresden, D-01307
Universitaet Wuerzburg/Hautkrankheiten
Würzburg, D-97080
Spain1 site
Institut Catala d'Oncologia - Hospital Duran i Reynals
Barcelona, 08907
About this study
Official title: Focal Fractionated Conformal Stereotactic Boost Following Conventional Radiotherapy of High Grade Gliomas: A Randomized Phase III Study
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.
Read the detailed description
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.
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, and then annually thereafter.
PROJECTED ACCRUAL: A total of 605 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- radiation therapy, stereotactic radiosurgery
- Keywords
- adult glioblastoma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Glioblastoma, Astrocytoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
stereotactic radiosurgeryRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2004 (estimated)
- Study startApr 1999
- Primary completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Brigitta Baumert, MD, PhD, Study chair, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003916
- Sponsor's protocol ID
- EORTC-22972-26991
- Other IDs
- EORTC-22972, EORTC-26991, MRC-BR10
- Status last verified
- Sep 2012
- First submitted
- 1 Nov 1999
- Last updated
- 24 Sep 2012
- Results posted
- No
Publications
Baumert BG, Brada M, Bernier J, Kortmann RD, Dehing-Oberije C, Collette L, Davis JB. EORTC 22972-26991/MRC BR10 trial: fractionated stereotactic boost following conventional radiotherapy of high grade gliomas. Clinical and quality-assurance results of the stereotactic boost arm. Radiother Oncol. 2008 Aug;88(2):163-72. doi: 10.1016/j.radonc.2008.03.025. Epub 2008 Apr 30.
PubMed 18455252Brada M, Baumert B. Focal fractionated conformal stereotactic boost following conventional radiotherapy of high-grade gliomas: a randomized phase III study. A joint study of the EORTC (22972) and the MRC (BR10). Front Radiat Ther Oncol. 1999;33:241-3. doi: 10.1159/000061233. No abstract available.
PubMed 10549493
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Fractionated Conformal Stereotactic Boost Following Conventional Radiotherapy of High Grade Gliomas: A Randomized Phase III Study
- ClinicalTrials.gov ID
- NCT00003916
- Acronym / sponsor ID
- EORTC-22972-26991
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult glioblastoma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Apr 1999
- Primary completion
- Dec 2001 (actual)
- First posted
- 16 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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, and then annually thereafter.
PROJECTED ACCRUAL: A total of 605 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiation therapy | Radiation | – |
| stereotactic radiosurgery | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
- Results publication: PubMed 18455252Baumert BG, Brada M, Bernier J, Kortmann RD, Dehing-Oberije C, Collette L, Davis JB. EORTC 22972-26991/MRC BR10 trial: fractionated stereotactic boost following conventional radiotherapy of high grade gliomas. Clinical and quality-assurance results of the stereotactic boost arm. Radiother Oncol. 2008 Aug;88(2):163-72. doi: 10.1016/j.radonc.2008.03.025. Epub 2008 Apr 30.
- Results publication: PubMed 10549493Brada M, Baumert B. Focal fractionated conformal stereotactic boost following conventional radiotherapy of high-grade gliomas: a randomized phase III study. A joint study of the EORTC (22972) and the MRC (BR10). Front Radiat Ther Oncol. 1999;33:241-3. doi: 10.1159/000061233. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitta Baumert, MD, PhD study chair
UniversitaetsSpital Zuerich
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing radiation therapy and stereotactic radiosurgery in people with Brain and Central Nervous System Tumors, run by European Organisation for Research and Treatment of Cancer - EORTC at 8 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Australia, France, Netherlands, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003916, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.