New radiation technique tested for aggressive brain cancer
NCT ID NCT01507506
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tested two types of radiation therapy for glioblastoma, a fast-growing brain tumor. One group received standard 3D radiation, while the other got a more precise intensity-modulated radiation guided by MRI scans. Both groups also took the chemotherapy drug temozolomide. The study aimed to see if the newer radiation method could help patients live longer. However, the trial was stopped early, so we don't have full results.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Temozolomide (chemotherapy) and radiotherapy (radiation)
- What this could lead to
- If successful, this could show that a more precise radiation technique improves survival for people with glioblastoma.
- What could go wrong
- The trial was terminated early, so results are limited. It is unclear if the experimental approach is better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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180 people
The number who actually took part.
- Started
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Mar 2011
- Finished
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Jan 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients must have unifocal glioblastoma (grade IV astrocytoma, WHO classification). The GBM can be: * Or resectable and the patient has received curative surgery * Or unresectable, and the largest tumor diameter (contrast enhancement) must be less than 5 cm on MRI 2. In all cases, the diagnosis must be confirmed by a pathologist. In patients for whom surgery is not possible, the diagnosis is confirmed by a biopsy of tumor tissue. 3. Methylation status of MGMT gene promoter is known 4. Patients who have undergone resection should have received an MRI or a scan after surgery in order to visualize residual tumor. If not, the operative report must be available. 5. Surgery or biopsy must have occurred 45 days before the start of radiotherapy. 6. WHO ≤ 2 7. Age ≥ 18 years 8. Signed Consent collected before any specific procedure in the study 9. Patient member in a national insurance scheme Exclusion Criteria: 1. Signs of hemorrhage on pre-radiotherapy MRI preventing a good spectrometric analysis 2. Patient with multifocal glioblastoma 3. Tumor located within 2 cm of the optic chiasm 4. Patient with leptomeningeal metastases, 5. patients prone to epileptic seizures despite treatment with anticonvulsant 6. Patients who received other previous treatment for glioblastoma multiforme 7. Abnormal haematological results at inclusion with: * Neutrophils \< 1500/mm3 * Blood-platelets \< 100000/mm3 8. Severe or chronic renal insufficiency (creatinin clearance ≤ 30 ml/min calculated using Cockroft-Gault's formula 9. Patient unable to follow procedures, visits, examinations described in the study 10. Any usual formal indication against imaging examinations (important claustrophobia, pace maker ...) 11. Pregnant women or nursing mothers can not participate in the study. Women of childbearing age must have a negative pregnancy test within 72 hours prior to study entry 12. Men and women of childbearing age must use effective contraception at study entry and throughout the study 13. Any concomitant or previous malignant disease within 5 years prior to study entry 14. Any prior systemic chemotherapy within 5 years prior to inclusion (for malignant disease in medical history) 15. Any other medical conditions making the inclusion of the patient in the study inappropriate in the opinion of the investigator 16. Patient under legal guardianship
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AP HM - Hôpital La Timone
Marseille, 13385, France
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CHU de Strasbourg
Strasbourg, 67065, France
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Centre Georges François Leclerc
Dijon, 21000, France
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Centre Jean Perrin
Clermont-Ferrand, 63011, France
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Centre Leon Berard
Lyon, 69373, France
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Centre Marie Curie
Valence, 26953, France
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Centre Paul Strauss
Strasbourg, 67065, France
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Centre Val d'Aurelle
Montpellier, 34298, France
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Clinique Claude Bernard
Albi, 81000, France
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Hospices Civils de Lyon (Hôpital Lyon Sud/Hôpital P. Wertheimer)
Lyon, 69002, France
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Institut Claudius REGAUD
Toulouse, 31052, France
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Institut de Cancerologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42271, France
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