Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ultrafractionated brain irradiation - temozolomide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrafractionated brain irradiation | Radiation | 0.75 Gy a day, 5 times a week, for 6 weeks (total dose: 67.5 Gy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete response | defined as total regression of tumor area contrast in MRI, with stability or amelioration of neurological status of patient without corticoids | through study completion, 2 years |
| partial response | 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 | through study completion, 2 years |
| stabilization | corresponding to at least 50% diminution of tumor size in MRI, with stability of neurological status of patient receiving steady corticoid doses | through study completion, 2 years |
| progression | 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 | through study completion, 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| global survival | through study completion, 2 years | |
| treatment tolerance | evaluated by general, neurological and hematological status, according to National Cancer Institute-Common toxicity criteria (NCI-CTC) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Temozolomide | Drug | 75 mg/m2/day, 7 times a week, for 6 weeks (total 42 days) |
|
|
| through study completion, 2 years |
| survival without tumor recurrence | tumor recurrence detected with radiology examination | through study completion, 2 years |
| life quality | evaluated with European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ - C30) | through study completion, 2 years |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |