A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma
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ClinicalTrials.gov Identifier: NCT00943826 |
Recruitment Status :
Completed
First Posted : July 22, 2009
Results First Posted : May 20, 2013
Last Update Posted : September 25, 2017
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Glioblastoma |
Interventions |
Drug: Bevacizumab Drug: Temozolomide Radiation: Radiation therapy Drug: Placebo |
Enrollment | 921 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | The primary completion date for co-primary outcome of Progression-Free Survival (PFS) was 31 Mar 2012, whereas, the primary completion date for co-primary outcome of Overall Survival (OS) was 28 Feb 2013. Data for PFS and OS are reported according to these cut-off dates. |
Arm/Group Title | Bevacizumab + RT + Temozolomide | Placebo + RT + Temozolomide |
---|---|---|
Arm/Group Description | In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety. | In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety. |
Period Title: Concurrent Phase | ||
Started | 458 | 463 |
Treated | 452 | 459 |
Completed | 397 | 421 |
Not Completed | 61 | 42 |
Reason Not Completed | ||
Adverse Event | 50 | 27 |
Withdrew consent | 3 | 7 |
Refused treatment/Did not cooperate | 5 | 7 |
Administrative reasons | 2 | 1 |
Protocol Violation | 1 | 0 |
Period Title: Maintenance Phase | ||
Started | 396 [1] | 370 [1] |
Completed | 353 | 331 |
Not Completed | 43 | 39 |
Reason Not Completed | ||
Adverse Event | 31 | 30 |
Withdrew consent | 2 | 4 |
Refused treatment/Did not cooperate | 6 | 3 |
Administrative reasons | 4 | 1 |
Failure to return | 0 | 1 |
[1]
Some who completed previous period had discontinued, progressed, or died prior to this period.
|
||
Period Title: Monotherapy Phase | ||
Started | 269 [1] | 159 [1] |
Completed | 204 | 143 |
Not Completed | 65 | 16 |
Reason Not Completed | ||
Adverse Event | 42 | 5 |
Administrative reasons | 11 | 5 |
Refused treatment/ Did not cooperate | 8 | 2 |
Withdrew Consent | 2 | 3 |
Failure to return | 2 | 1 |
[1]
Some who completed previous period had discontinued, progressed, or died prior to this period.
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||
Period Title: After Primary Overall Survival Analysis | ||
Started | 27 [1] | 20 [1] |
Completed | 0 | 0 |
Not Completed | 27 | 20 |
Reason Not Completed | ||
Adverse Event | 11 | 0 |
Administrative reasons | 10 | 16 |
Progression of Disease | 2 | 4 |
Withdrew Consent | 4 | 0 |
[1]
Some who completed previous period had discontinued, progressed, or died prior to this period.
|
Baseline Characteristics
Arm/Group Title | Bevacizumab + RT + Temozolomide | Placebo + RT +Temozolomide | Total | |
---|---|---|---|---|
Arm/Group Description | In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety. | In the Concurrent Phase participants received RT in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety. | Total of all reporting groups | |
Overall Number of Baseline Participants | 458 | 463 | 921 | |
Baseline Analysis Population Description |
Intent to treat population included all randomized participants.
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 458 participants | 463 participants | 921 participants | |
55.9
(20 to 84)
|
55.9
(18 to 79)
|
55.9
(18 to 84)
|
||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 458 participants | 463 participants | 921 participants | |
Female |
176 38.4%
|
165 35.6%
|
341 37.0%
|
|
Male |
282 61.6%
|
298 64.4%
|
580 63.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: | Medical Communications |
Organization: | Hoffmann-La Roche |
Phone: | 800-821-8590 |
EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00943826 |
Other Study ID Numbers: |
BO21990 2008-006146-26 ( EudraCT Number ) |
First Submitted: | July 17, 2009 |
First Posted: | July 22, 2009 |
Results First Submitted: | March 29, 2013 |
Results First Posted: | May 20, 2013 |
Last Update Posted: | September 25, 2017 |