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The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma multiforme.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temozolomide + Radiation | Active Comparator | Standard therapy regimen: Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used. Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. |
|
| Temozolomide alone, then Temozolomide + Radiation | Experimental | Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temozolomide | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from randomization to death. OS was calculated by the Kaplan-Meier method. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS was defined as the length of time from randomization to disease progression (the length of time during which the cancer did not get worse) or death. PFS was calculated by the Kaplan-Meier method. | Up to 2 years |
| Objective Tumor Assessment After Surgery: Overall Response |
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Inclusion Criteria:
Only the patients who meet all these criteria can be enrolled in the study:
Patients with prior histological confirmation of newly diagnosed primary glioblastoma multiforme in supratentorial cerebral hemisphere.
Gross total resection or partial resection (imaging) >70%.
At least be capable to obtain a tissue sample for MGMT analysis during surgery.
Chemo-radiotherapy to be expected from Week 5 (Day 29) after surgery.
Age >=18 and <=70 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Life expectancy >=9 months.
Laboratory test values must satisfy the following criteria:
Patients must be willing to provide written informed consent.
Patients of child-bearing potential (including female subjects and the female partners of male subjects) must use an effective method of contraception.
Exclusion Criteria:
Patients will not be enrolled if any of the following criteria apply:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26481741 | Result | Mao Y, Yao Y, Zhang LW, Lu YC, Chen ZP, Zhang JM, Qi ST, You C, Wang RZ, Yang SY, Zhang X, Wang JS, Chen JX, Yang QY, Shen H, Li ZY, Wang X, Ma WB, Yang XJ, Zhen HN, Zhou LF. Does Early Postsurgical Temozolomide Plus Concomitant Radiochemotherapy Regimen Have Any Benefit in Newly-diagnosed Glioblastoma Patients? A Multi-center, Randomized, Parallel, Open-label, Phase II Clinical Trial. Chin Med J (Engl). 2015 Oct 20;128(20):2751-8. doi: 10.4103/0366-6999.167313. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Temozolomide + Radiation | Standard therapy regimen: Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used. Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Radiotherapy | Radiation |
|
|
Overall response was based on neuroimaging (magnetic resonance imaging [MRI]), clinical neurological examination, and steroid administration. It was assessed as follows: Complete Response (CR): Disappearance of all enhancing tumor (measurable or non-measurable), no corticosteroid use, and neurologically stable or improved. Partial Response (PR): ≥50% reduction in size of enhancing tumor (measurable or non-measurable) for any measurable lesions or definite improvement for any non-measurable lesions, corticosteroid dosage stable or reduced, and neurologically stable or improved. Progressive Disease (PD): ≥25% increase in contrast enhancement for any measurable lesions or definite worsening for any non-measurable lesions, or any new tumor on MRI scans, at an increased dose of corticosteroid, with or without neurologic progression. Clinical or radiological worsening resulting from other than tumor factors were excluded. Stable Disease (SD): All other situations. |
| Up to 2 years |
| Relationship Between O6-methylguanine-DNA Methyltransferase (MGMT) Status and Therapy Response: Overall Survival for the MGMT Positive Group | MGMT was measured by immunohistochemistry (IHC). OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive. OS was calculated by the Kaplan-Meier method. | Up to 2 years |
| Relationship Between MGMT Status and Therapy Response: Overall Survival for the MGMT Negative Group | MGMT was measured by IHC. OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive. OS was calculated by the Kaplan-Meier method. | Up to 2 years |
| Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Positive Group | MGMT was measured by IHC. OS rate was defined as the percentage of participants who were still alive 6, 12, & 18 months after starting study treatment. OS was calculated by the Kaplan-Meier method. | 6, 12, & 18 months |
| Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Negative Group | MGMT was measured by IHC. OS rate was defined as the percentage of participants who were still alive 6, 12, & 18 months after starting study treatment. OS was calculated by the Kaplan-Meier method. | 6, 12, & 18 months |
| Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Positive Group | MGMT was measured by IHC. PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse. PFS was calculated by the Kaplan-Meier method. | Up to 2 years |
| Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Negative Group | MGMT was measured by IHC. PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse. PFS was calculated by the Kaplan-Meier method. | Up to 2 years |
| FG001 | Temozolomide Alone, Then Temozolomide + Radiation | Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Temozolomide + Radiation | Standard therapy regimen: Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used. Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. |
| BG001 | Temozolomide Alone, Then Temozolomide + Radiation | Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Overall Survival (OS) | OS was defined as the time from randomization to death. OS was calculated by the Kaplan-Meier method. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
|
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| |||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | PFS was defined as the length of time from randomization to disease progression (the length of time during which the cancer did not get worse) or death. PFS was calculated by the Kaplan-Meier method. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
| |||||||||||||||||||||||||||||||
| Secondary | Objective Tumor Assessment After Surgery: Overall Response | Overall response was based on neuroimaging (magnetic resonance imaging [MRI]), clinical neurological examination, and steroid administration. It was assessed as follows: Complete Response (CR): Disappearance of all enhancing tumor (measurable or non-measurable), no corticosteroid use, and neurologically stable or improved. Partial Response (PR): ≥50% reduction in size of enhancing tumor (measurable or non-measurable) for any measurable lesions or definite improvement for any non-measurable lesions, corticosteroid dosage stable or reduced, and neurologically stable or improved. Progressive Disease (PD): ≥25% increase in contrast enhancement for any measurable lesions or definite worsening for any non-measurable lesions, or any new tumor on MRI scans, at an increased dose of corticosteroid, with or without neurologic progression. Clinical or radiological worsening resulting from other than tumor factors were excluded. Stable Disease (SD): All other situations. | Posted | Number | participants | Up to 2 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Relationship Between O6-methylguanine-DNA Methyltransferase (MGMT) Status and Therapy Response: Overall Survival for the MGMT Positive Group | MGMT was measured by immunohistochemistry (IHC). OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive. OS was calculated by the Kaplan-Meier method. | Participants with enough tissue to perform MGMT analysis. Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 5. | Posted | Median | Standard Deviation | months | Up to 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Relationship Between MGMT Status and Therapy Response: Overall Survival for the MGMT Negative Group | MGMT was measured by IHC. OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive. OS was calculated by the Kaplan-Meier method. | Participants with enough tissue to perform MGMT analysis. Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 4. | Posted | Median | Standard Deviation | months | Up to 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Positive Group | MGMT was measured by IHC. OS rate was defined as the percentage of participants who were still alive 6, 12, & 18 months after starting study treatment. OS was calculated by the Kaplan-Meier method. | Participants with enough tissue to perform MGMT analysis. Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 7. | Posted | Number | 95% Confidence Interval | percentage of participants | 6, 12, & 18 months |
| ||||||||||||||||||||||||||||||
| Secondary | Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Negative Group | MGMT was measured by IHC. OS rate was defined as the percentage of participants who were still alive 6, 12, & 18 months after starting study treatment. OS was calculated by the Kaplan-Meier method. | Participants with enough tissue to perform MGMT analysis. Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 6. | Posted | Number | 95% Confidence Interval | percentage of participants | 6, 12, & 18 months |
| ||||||||||||||||||||||||||||||
| Secondary | Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Positive Group | MGMT was measured by IHC. PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse. PFS was calculated by the Kaplan-Meier method. | Participants with enough tissue to perform MGMT analysis. Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 9. | Posted | Median | Standard Deviation | months | Up to 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Negative Group | MGMT was measured by IHC. PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse. PFS was calculated by the Kaplan-Meier method. | Participants with enough tissue to perform MGMT analysis. Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 8. | Posted | Median | Standard Deviation | months | Up to 2 years |
|
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Population is all treated participants.
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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 Radiation | Standard therapy regimen: Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used. Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. | 11 | 42 | 24 | 42 | ||
| EG001 | Temozolomide Alone, Then Temozolomide Radiation | Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. | 11 | 52 | 22 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| DISEASE RECURRENCE | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| CENTRAL NERVOUS SYSTEM INFECTION | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| BRAIN HERNIATION | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| NEOPLASM RECURRENCE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| INTRACRANIAL PRESSURE INCREASED | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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The Institution and Principal Investigator (PI) have the right to publish/present study results. PI and Institution agree not to publish/present any interim study results. PI and Institution further agree to provide 30 days written notice to Sponsor prior to submission for publication or presentation to permit Sponsor to review drafts of abstracts and manuscripts for publication which report any study results. Sponsor shall have the right to review and comment on any Public Presentation.
| 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 |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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Not provided
| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
Not provided
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| Male |
|
|
|
| OG001 | Temozolomide Alone, Then Temozolomide + Radiation | Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. |
|
|
Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. |
|
|
|
Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. |
|
|
|
Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. |
|
|
Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. |
|
|
Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. |
|
|
|
Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. |
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