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This study was to explore the effectiveness and safety of early TMZ chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen.
This study was to explore the effectiveness and safety of early temozolomide chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen. Patients were treated with a standard therapy regimen (Stupp) plus early postsurgical temozolomide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early TMZ chemotherapy | Experimental | Patients were treated with standard concomitant radiochemotherapy regimen (Stupp) plus early postsurgical temozolomide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temozolomide | Drug | Two weeks after surgery, temozolomide was administered orally at 200 mg·m-2 ·d -1 for 5 days. From day 29, patients were treated with a standard therapy regimen (Stupp). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival | 5-year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Progression free survival | 5-year |
| Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants |
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Inclusion Criteria:
Age: 18 years to 70 years; Newly diagnosed Glioblastoma in the supratentorial cerebral hemisphere; Gross total resection or large resection of >70% in imaging studies; Eastern Cooperative Oncology Group performance status of 0-2; Adequate bone marrow, liver and renal function; Ability of subject to understand character and individual consequences of the clinical trial Written informed consent; anticipating survival ≥7 months.
Exclusion Criteria:
Refusal to participate the study; Current diagnosis or history of malignancies within the 3-year period preceding enrollment; Recurrent or multiple malignant gliomas, including gliomatosis cerebri, or metastatic extracalvarial or subtentorial lesions; Known hypersensitivity or contraindication to temozolomide; Pregnant or lactating females; Malignant tumor other than brain tumor; Contraindicated for MRI examination; Unable to comply with the follow-up studies of this trial; Uncontrolled psychotic disorders or epilepsy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mou Y Gao, MD, PhD | Contact | +86-20-87343821 | Mouyg@sysucc.org.cn | |
| Guo C Cheng, MD, PhD | Contact | +86-20-87343309 | guochch@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Mou Y Gao, MD, PhD | Department of Neurosurgery/Neuro-oncology, Sun Yat-sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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|
Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants |
| 5-year |
| 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 |