Glioblastoma Multiforme
Conditions
Brief summary
The main purpose of this study is the evaluation of concomitant association of ultrafractionated irradiation and Temodal® in patients with inoperable primary glioblastoma multiforme; study of tolerance and objective response rate. 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.
Interventions
RADIATIONUltrafractionated brain irradiation
0.75 Gy a day, 5 times a week, for 6 weeks (total dose: 67.5 Gy)
DRUGTemozolomide
75 mg/m2/day, 7 times a week, for 6 weeks (total 42 days)
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* giving their informed consent * 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 an under tentorial malignant glioma (brain stem and/or cerebellum), grade 4 of St. Anne/Mayo grading * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression | through study completion, 2 years | defined by increase of at least 25% of tumor size and/or a second brain localization in MRI, with degradation of neurological status of patient |
| complete response | through study completion, 2 years | defined as total regression of tumor area contrast in MRI, with stability or amelioration of neurological status of patient without corticoids |
| partial response | through study completion, 2 years | defined by at least 50% diminution of tumor size, evaluated by the product of 2 perpendicular diameters measured by MRI, with stability or amelioration of neurological status of patient receiving stable or reduced corticoid doses |
| stabilization | through study completion, 2 years | corresponding to at least 50% diminution of tumor size in MRI, with stability of neurological status of patient receiving steady corticoid doses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| global survival | through study completion, 2 years | — |
| treatment tolerance | through study completion, 2 years | evaluated by general, neurological and hematological status, according to National Cancer Institute-Common toxicity criteria (NCI-CTC) |
| survival without tumor recurrence | through study completion, 2 years | tumor recurrence detected with radiology examination |
| life quality | through study completion, 2 years | evaluated with European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ - C30) |
Outcome results
None listed