Trial · NCT00597402
Avastin in Combination With Radiation (XRT) & Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma (GBM) and Gliosarcomas
NCT00597402, Phase 2, Completed, Duke University; results first posted 2013-01-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Avastin in Combination With Radiation (XRT) & Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma (GBM) and Gliosarcomas. Trials, record NCT00597402. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00597402
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Avastin in Combination With Radiation (XRT) & Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma (GBM) and Gliosarcomas
- NCT number
- NCT00597402
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 125 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Glioblastoma, Gliosarcoma, Brain Tumor
- Interventions
- Avastin, Temozolomide, Radiation Therapy (XRT), Irinotecan
- First posted
- 2008-01-18
- Last updated
- 2014-05-07
- Results first posted
- 2013-01-18
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 16-month Overall Survival (OS) | 16 months | Percentage of participants surviving sixteen months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of death due to any cause. |
| Secondary | 12-month Progression-free Survival (PFS) | 12 months | Percentage of participants surviving twelve months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. |
| Secondary | Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage | 55 months | Number of times a CNS hemorrhage or systemic hemorrhage was experienced |
| Secondary | Number of Patients Experiencing a Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity | 55 months | Number of times a grade ≥ 4 hematologic or grade ≥ 3 non-hematologic toxicity was experienced |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 16-month Overall Survival (OS) | 16 months | Intent to treat | percentage of participants | NUMBER |
| SECONDARY | 12-month Progression-free Survival (PFS) | 12 months | percentage of participants | NUMBER | |
| SECONDARY | Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage | 55 months | participants | NUMBER | |
| SECONDARY | Number of Patients Experiencing a Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity | 55 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 16-month Overall Survival (OS) | Avastin, Radiation, Temozolomide, and Irinotecan | 64.8 | 95% Confidence Interval 55.7 to 72.5 | percentage of participants | |
| 12-month Progression-free Survival (PFS) | Avastin, Radiation, Temozolomide, and Irinotecan | 63.2 | 95% Confidence Interval 54.1 to 71.0 | percentage of participants | |
| Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage | Avastin, Radiation, Temozolomide, and Irinotecan | Gr.2 Central Nervous System (CNS) Hemorrhage | 1 | participants | |
| Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage | Avastin, Radiation, Temozolomide, and Irinotecan | Gr.3 Central Nervous System (CNS) Hemorrhage | 0 | participants | |
| Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage | Avastin, Radiation, Temozolomide, and Irinotecan | Gr.4 Central Nervous System (CNS) Hemorrhage | 1 | participants | |
| Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage | Avastin, Radiation, Temozolomide, and Irinotecan | Gr.5 Central Nervous System (CNS) Hemorrhage | 0 | participants | |
| Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage | Avastin, Radiation, Temozolomide, and Irinotecan | Gr.2 Systemic Hemorrhage | 1 | participants | |
| Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage | Avastin, Radiation, Temozolomide, and Irinotecan | Gr.3 Systemic Hemorrhage | 0 | participants | |
| Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage | Avastin, Radiation, Temozolomide, and Irinotecan | Gr.4 Systemic Hemorrhage | 0 | participants | |
| Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage | Avastin, Radiation, Temozolomide, and Irinotecan | Gr.5 Systemic Hemorrhage | 0 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Avastin, Radiation, Temozolomide, and Irinotecan | 125 | |
| Overall Study | COMPLETED | Avastin, Radiation, Temozolomide, and Irinotecan | 125 | |
| Overall Study | NOT COMPLETED | Avastin, Radiation, Temozolomide, and Irinotecan | 0 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Avastin, Radiation, Temozolomide, and Irinotecan | 10 | 125 | |
| other | Neutrophil count decreased | Investigations | Avastin, Radiation, Temozolomide, and Irinotecan | 25 | 125 | |
| other | Platelet count decreased | Investigations | Avastin, Radiation, Temozolomide, and Irinotecan | 23 | 125 | |
| serious | Anemia | Blood and lymphatic system disorders | Avastin, Radiation, Temozolomide, and Irinotecan | 4 | 125 | |
| serious | Atrial fibrillation | Cardiac disorders | Avastin, Radiation, Temozolomide, and Irinotecan | 1 | 125 | |
| serious | Colitis | Gastrointestinal disorders | Avastin, Radiation, Temozolomide, and Irinotecan | 1 | 125 | |
| serious | Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Avastin, Radiation, Temozolomide, and Irinotecan | 1 | 125 | |
| serious | Hemorrhoids | Gastrointestinal disorders | Avastin, Radiation, Temozolomide, and Irinotecan | 1 | 125 | |
| serious | Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Avastin, Radiation, Temozolomide, and Irinotecan | 1 | 125 | |
| serious | Death NOS | General disorders | Avastin, Radiation, Temozolomide, and Irinotecan | 2 | 125 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Avastin, Radiation, Temozolomide, and Irinotecan | ||
| Total, other adverse events | Avastin, Radiation, Temozolomide, and Irinotecan | 45 | 125 |
| Total, serious adverse events | Avastin, Radiation, Temozolomide, and Irinotecan | 35 | 125 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00597402
GET https://conductscience.org/api/trials/v1/NCT00597402/events?page=2