Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme
NCT ID: NCT03310372
Last Updated: 2017-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2008-02-13
2012-06-26
Brief Summary
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The secondary purposes of this study are the evaluation of progression free survival, global survival and tolerance through toxicity study. The therapeutic response according to methylation or not of MGMT is also evaluated.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ultrafractionated brain irradiation - temozolomide
Ultrafractionated brain irradiation
0.75 Gy a day, 5 times a week, for 6 weeks (total dose: 67.5 Gy)
Temozolomide
75 mg/m2/day, 7 times a week, for 6 weeks (total 42 days)
Interventions
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Ultrafractionated brain irradiation
0.75 Gy a day, 5 times a week, for 6 weeks (total dose: 67.5 Gy)
Temozolomide
75 mg/m2/day, 7 times a week, for 6 weeks (total 42 days)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* having a supratentorial malignant glioma, either grade 4 of St. Anne/Mayo grading, or glioblastoma multiforme according to WHO classification
* having an inoperable brain tumor (diagnosed by stereotactic biopsy)
* having a general status, evaluated by Karnofsky scale, \>60
* having a life expectancy \>3 months
* not having previously had a brain irradiation and/or adjuvant or neo-adjuvant chemotherapy
* potentially having another cancer, if histology and clinical history are available for comparison
* being able to take oral tablets
* no HIV disease
* satisfactory hematology, hepatic and renal functions: polymorphonuclear neutrophils \>1500/mm3, platelets \>100000/mm3, Hb \>8g/dl, creatinemia ≤1.5 times upper normal value, total bilirubin \<1.5 times upper normal value, ASAT and ALAT \<3 times upper normal value
* for women of childbearing potential, a contraception is given
Exclusion Criteria
* having a Karnofsky score \<60
* having a life expectancy \<3 months
* having had a brain irradiation or an adjuvant or neoadjuvant chemotherapy
* refusing any additional therapy
* having a non-malignant but serious systemic disease or uncontrolled active infection
* having a severe psychiatric disorder
* not having signed the informed consent
* pregnant or breastfeeding woman
18 Years
74 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Other Identifiers
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2007-004968-41
Identifier Type: -
Identifier Source: org_study_id