Trial · NCT00492089
Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer
NCT00492089, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-06-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer. Trials, record NCT00492089. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00492089
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer
- NCT number
- NCT00492089
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Meningioma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Central Nervous System Germ Cell Tumor, Adult Choroid Plexus Tumor, Adult Diffuse Astrocytoma, Adult Ependymoma, Adult Grade II Meningioma, Adult Grade III Meningioma, Adult Malignant Hemangiopericytoma, Adult Mixed Glioma, Adult Oligodendroglioma, Adult Papillary Meningioma, Adult Pineocytoma, Malignant Neoplasm, Meningeal Melanocytoma, Radiation Toxicity, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Adult Brain Tumor, Recurrent Basal Cell Carcinoma of the Lip, Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Recurrent Lymphoepithelioma of the Nasopharynx, Recurrent Lymphoepithelioma of the Oropharynx, Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Stage I Adenoid Cystic Carcinoma of the Oral Cavity, Stage I Basal Cell Carcinoma of the Lip, Stage I Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Stage I Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Stage I Lymphoepithelioma of the Nasopharynx, Stage I Lymphoepithelioma of the Oropharynx, Stage I Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Stage I Mucoepidermoid Carcinoma of the Oral Cavity, Stage I Salivary Gland Cancer, Stage I Squamous Cell Carcinoma of the Hypopharynx, Stage I Squamous Cell Carcinoma of the Larynx, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage I Squamous Cell Carcinoma of the Nasopharynx, Stage I Squamous Cell Carcinoma of the Oropharynx, Stage I Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage I Verrucous Carcinoma of the Larynx, Stage I Verrucous Carcinoma of the Oral Cavity, Stage III Adenoid Cystic Carcinoma of the Oral Cavity, Stage III Basal Cell Carcinoma of the Lip, Stage III Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Stage III Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Stage III Lymphoepithelioma of the Nasopharynx, Stage III Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Stage III Mucoepidermoid Carcinoma of the Oral Cavity, Stage III Salivary Gland Cancer, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage III Verrucous Carcinoma of the Larynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IV Adenoid Cystic Carcinoma of the Oral Cavity, Stage IV Basal Cell Carcinoma of the Lip, Stage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Stage IV Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Stage IV Lymphoepithelioma of the Nasopharynx, Stage IV Lymphoepithelioma of the Oropharynx, Stage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Stage IV Mucoepidermoid Carcinoma of the Oral Cavity, Stage IV Salivary Gland Cancer, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IV Verrucous Carcinoma of the Larynx, Stage IV Verrucous Carcinoma of the Oral Cavity
- Interventions
- bevacizumab, placebo, magnetic resonance imaging, quality-of-life assessment
- First posted
- 2007-06-27
- Last updated
- 2014-05-09
- Results first posted
- 2013-06-14
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment | Baseline to 12 weeks | Change in magnetic resonance imaging (MRI) from baseline to evaluation at 6 weeks for participants where MRI changes are based on the size of edema (T2 FLAIR) and Gd-contrast enhancement (lesion diameter and perfusion/dynamic). A 25% reduction in T2 flair volume constitutes a response for study. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment | Baseline to 12 weeks | Analysis was conducted per protocol. The participants in the Crossover Arm were evaluated after receiving the Bevacizumab treatment as described in the arm description. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment | Arm A: Bevacizumab | 5 | participants | ||
| Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment | Crossover Arm B: Placebo Then Bevacizumab | 6 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (6 Weeks) | STARTED | Arm A: Bevacizumab | 5 | |
| First Intervention (6 Weeks) | STARTED | Crossover Arm B: Placebo First, Then Bevacizumab | 6 | |
| First Intervention (6 Weeks) | COMPLETED | Arm A: Bevacizumab | 5 | |
| First Intervention (6 Weeks) | COMPLETED | Crossover Arm B: Placebo First, Then Bevacizumab | 6 | |
| First Intervention (6 Weeks) | NOT COMPLETED | Arm A: Bevacizumab | 0 | |
| First Intervention (6 Weeks) | NOT COMPLETED | Crossover Arm B: Placebo First, Then Bevacizumab | 0 | |
| Second Intervention (6 Weeks) | STARTED | Arm A: Bevacizumab | 5 | |
| Second Intervention (6 Weeks) | STARTED | Crossover Arm B: Placebo First, Then Bevacizumab | 6 | |
| Second Intervention (6 Weeks) | COMPLETED | Arm A: Bevacizumab | 5 | |
| Second Intervention (6 Weeks) | COMPLETED | Crossover Arm B: Placebo First, Then Bevacizumab | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events16
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 | Hypertension | Cardiac disorders | Bevacizumab | 4 | 11 | 4 |
| other | Hypertension | Cardiac disorders | Placebo | 0 | 6 | 0 |
| other | Fatigue | General disorders | Bevacizumab | 3 | 11 | 3 |
| other | Fatigue | General disorders | Placebo | 0 | 6 | 0 |
| other | Elevated alanine aminotransferase (ALT) | Hepatobiliary disorders | Bevacizumab | 2 | 11 | 2 |
| other | Elevated alanine aminotransferase (ALT) | Hepatobiliary disorders | Placebo | 0 | 6 | 0 |
| other | Nausea | Gastrointestinal disorders | Bevacizumab | 1 | 11 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 6 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bevacizumab | 1 | 11 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 0 | 6 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Bevacizumab | 5 | 11 |
| Total, other adverse events | Placebo | 0 | 6 |
| Total, serious adverse events | Bevacizumab | 4 | 11 |
| Total, serious adverse events | Placebo | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Bevacizumab vs Crossover Arm B: Placebo Then Bevacizumab: Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment | Trial comparisons |
| Bevacizumab vs Placebo: serious adverse events | Trial comparisons |
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/NCT00492089
GET https://conductscience.org/api/trials/v1/NCT00492089/registered