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The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a routine care setting.
Participant sampling method: consecutive patient sampling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Participants with newly diagnosed Glioblastoma multiforme who were prescribed temozolomide and radiotherapy as standard care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temozolomide | Drug | Temozolomide will be administered orally at 75 mg/m^2 with radiotherapy during the concomitant treatment phase. After four weeks, temozolomide will be administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of Adverse Events in the Indicated Categories | Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase | |
| Number of Participants Who Discontinued Due to Toxicity | Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with newly diagnosed Glioblastoma multiforme
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| ID | Title | Description |
|---|---|---|
| FG000 | Planned Temozolomide+Radiotherapy | Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Planned Temozolomide+Radiotherapy | Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety: Number of Adverse Events in the Indicated Categories | Posted | Number | Adverse Events | Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Temozolomide+Radiotherapy | Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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|
|
| Radiotherapy | Radiation | Radiotherapy will consist of fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase. |
|
|
| Death |
|
| Lost to Follow-up |
|
| Hepatopathy probably not Temodal-related |
|
| Suspect lymph nodes neck thorax abdomen |
|
| No further documentation |
|
| Intensified treatment scheme: 3 on 1 off |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Temozolomide Alone |
Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles. |
|
|
| Primary | Number of Participants Who Discontinued Due to Toxicity | Posted | Number | Participants | Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase |
|
|
|
| 8 |
| 44 |
| 12 |
| 44 |
| EG001 | Temozolomide Alone | Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles. | 1 | 6 | 1 | 6 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
|
| Dural fistula | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
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| 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 |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |