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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
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This study aimed to investigate the clinical benefit contribution and safety of nimotuzumab to the standard combined treatment for patients with newly diagnosed glioblastoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab plus RT and temozolomide. | Experimental | Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Biological | Nimotuzumab, 200 mg as 1-hour intravenous infusion once weekly, from first week to last week of RT for a total of 6 times. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS will be calculated as the time from surgery to the date of progression-free. | 2 years |
| Overall survival (OS) | OS will be calculated as the time from surgery to the date of death. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR: overall response rate (ORR), subjects will be classified according to the RANO criteria, which is a composite of MRI changes, clinical response and changes in steroid use. | 6 months |
| Incidence of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shao-Xiong Wu, Professor | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China | ||
| Guangdong Brain Hospital |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Temozolomide | Drug | Temozolomide, 75 mg/m2/d was administered orally from the first to the last day of RT. After 4-week break, individualized adjuvant TMZ was given based on MGMT status. The standard 5-day schedule every 4 weeks for six cycles was given for patients with negative MGMT expression. Dose was 150mg/m2 for the first cycle and 200 mg/m2 from the second cycle. The 7-day on/7-day off schedule every 2 weeks for 12 cycles was given for patients with positive MGMT expression. The dose was 100 mg/m2 for the first two cycles and 150 mg/m2 starting from the third cycle. |
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| Radiotherapy | Radiation | Fractionated 3D conformal RT was given at 2.0Gy per fraction, 5 daily fractions per week for 6 weeks. |
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Incidence of adverse events.Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 3.
| 6 months |
| Guangdong |
| China |
| The First Affiliated Hospital/School of Clinical Medicine of Guangdong | Guangdong | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | China |
| Shenzhen People's Hospital | Shenzhen | China |
| 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 |
| D013812 | Therapeutics |