Status:
TERMINATED
Phase III Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in the Treatment of Glioblastoma
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a multi-institutional phase III clinical study of interventional type. The trial will include 220 patients with confirmed unifocal glioblastoma over a period of 3 years + 3 years of follow up....
Eligibility Criteria
Inclusion
- 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
- 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.
- Methylation status of MGMT gene promoter is known
- 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.
- Surgery or biopsy must have occurred 45 days before the start of radiotherapy.
- WHO ≤ 2
- Age ≥ 18 years
- Signed Consent collected before any specific procedure in the study
- Patient member in a national insurance scheme
Exclusion
- Signs of hemorrhage on pre-radiotherapy MRI preventing a good spectrometric analysis
- Patient with multifocal glioblastoma
- Tumor located within 2 cm of the optic chiasm
- Patient with leptomeningeal metastases,
- patients prone to epileptic seizures despite treatment with anticonvulsant
- Patients who received other previous treatment for glioblastoma multiforme
- Abnormal haematological results at inclusion with:
- Neutrophils \< 1500/mm3
- Blood-platelets \< 100000/mm3
- Severe or chronic renal insufficiency (creatinin clearance ≤ 30 ml/min calculated using Cockroft-Gault's formula
- Patient unable to follow procedures, visits, examinations described in the study
- Any usual formal indication against imaging examinations (important claustrophobia, pace maker ...)
- 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
- Men and women of childbearing age must use effective contraception at study entry and throughout the study
- Any concomitant or previous malignant disease within 5 years prior to study entry
- Any prior systemic chemotherapy within 5 years prior to inclusion (for malignant disease in medical history)
- Any other medical conditions making the inclusion of the patient in the study inappropriate in the opinion of the investigator
- Patient under legal guardianship
Key Trial Info
Start Date :
March 15 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2020
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01507506
Start Date
March 15 2011
End Date
January 2 2020
Last Update
January 12 2021
Active Locations (12)
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1
Clinique Claude Bernard
Albi, France, 81000
2
Centre Jean Perrin
Clermont-Ferrand, France, 63011
3
Centre Georges François Leclerc
Dijon, France, 21000
4
Hospices Civils de Lyon (Hôpital Lyon Sud/Hôpital P. Wertheimer)
Lyon, France, 69002