Trial · NCT00643565
A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
NCT00643565, Phase 2, Completed, Hoffmann-La Roche; results first posted 2016-02-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma. Trials, record NCT00643565. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00643565
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
- NCT number
- NCT00643565
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 154 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Sarcoma
- Interventions
- Standard chemotherapy, bevacizumab [Avastin]
- First posted
- 2008-03-26
- Last updated
- 2019-10-22
- Other registries' IDs
- eudract:2007-005017-19
- Results first posted
- 2016-02-12
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Experienced Event-Free Survival (EFS) Events as Per Independent Review Committee (IRC) Assessment | Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years) | EFS events included tumor progression (IRC assessed), no evidence of response after 3 cycles of induction (derived from IRC assessment), second primary cancer, or death due to any cause. Data for participants who had not experienced an event by the time of clinical cut-off were censored at the date of the last disease assessment prior to the clinical cut-off date. Data for participants who did not have any post-baseline disease assessments were censored at the time of randomization. Tumor progression was defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions. |
| Primary | EFS Duration as Per IRC Assessment | Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years) | EFS was defined as the time between randomization and occurrence of EFS event. EFS events are described in Outcome Measure 1. Median EFS was estimated using Kaplan-Meier estimates and 95% confidence intervals (CI) for median was computed using the method of Brookmeyer and Crowley. |
| Secondary | Percentage of Participants With Objective Response Prior to First Local Therapy Assessed by RECIST v1.0 Criteria | Screening up to approximately 6.75 years | Objective response prior to first local therapy (surgery and/or radiotherapy) was defined as complete response (CR) or partial response (PR) determined on two consecutive occasions \>/=4 weeks apart. Tumor response was assessed as per IRC using RECIST v1.0. CR was defined as disappearance of all target and non-target lesions. If immunocytology was available, no disease was to be detected by that methodology. PR was defined as at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. |
| Secondary | Percentage of Participants Who Experienced EFS Events Among Participants Who Had Objective Response | Screening up to approximately 6.75 years | EFS events was described in Outcome Measure 1 and Outcome Measure 3. |
| Secondary | Duration of Response | Screening up to approximately 6.75 years | Duration of Response was defined as time between first objective response and the occurrence of an EFS event (described in Outcome Measure 1). Objective response was defined in Outcome Measure 3. Median duration of response was estimated using Kaplan-Meier estimates and 95% CI for median was computed using the method of Brookmeyer and Crowley. |
| Secondary | Percentage of Participants Who Died | Screening up to approximately 10.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years. | |
| Secondary | Overall Survival Duration | Screening up to approximately 10.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years) | Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Median overall survival was estimated using Kaplan-Meier estimates and 95% CI for median was computed using the method of Brookmeyer and Crowley. |
| Secondary | Area Under the Curve at Steady State (AUCss) of Bevacizumab | Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUCss is expressed in milligrams times days per milliliter (mg\*day/mL). |
| Secondary | Volume of Distribution of Bevacizumab | Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. |
| Secondary | Half-Life of Bevacizumab | Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks) | Half-life is the time measured for the plasma concentration to decrease by one half. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experienced Event-Free Survival (EFS) Events as Per Independent Review Committee (IRC) Assessment | Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years) | ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response Prior to First Local Therapy Assessed by RECIST v1.0 Criteria | Screening up to approximately 6.75 years | ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced EFS Events Among Participants Who Had Objective Response | Screening up to approximately 6.75 years | ITT population. Here number of participants analyzed = participants available for the analysis of this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | Screening up to approximately 6.75 years | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Percentage of Participants Who Died | Screening up to approximately 10.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years. | ITT population. | percentage of participants | NUMBER |
| PRIMARY | EFS Duration as Per IRC Assessment | Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years) | ITT population. | months | MEDIAN |
| SECONDARY | Overall Survival Duration | Screening up to approximately 10.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years) | ITT population. Here number of participants analyzed = participants available for the analysis of this outcome measure. | months | MEDIAN |
| SECONDARY | Area Under the Curve at Steady State (AUCss) of Bevacizumab | Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase | Pharmacokinetic (PK)-evaluable population included all randomized participants for whom at least one blood sample was taken for PK assessment following bevacizumab administration. Here, number of participants analyzed = participants who were evaluable for this outcome measure. | mg*day/mL | MEAN |
| SECONDARY | Volume of Distribution of Bevacizumab | Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks) | PK-evaluable population. Only participants who received bevacizumab were to be analyzed for PK assessment. | mL | MEAN |
| SECONDARY | Half-Life of Bevacizumab | Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks) | PK-evaluable population. Only participants who received bevacizumab were to be analyzed for PK assessment. | days | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Experienced Event-Free Survival (EFS) Events as Per Independent Review Committee (IRC) Assessment | Chemotherapy | 52.5 | percentage of participants | ||
| Percentage of Participants Who Experienced Event-Free Survival (EFS) Events as Per Independent Review Committee (IRC) Assessment | Bevacizumab + Chemotherapy | 68.9 | percentage of participants | ||
| Percentage of Participants With Objective Response Prior to First Local Therapy Assessed by RECIST v1.0 Criteria | Chemotherapy | 36.0 | 95% Confidence Interval 25.23 to 47.91 | percentage of participants | |
| Percentage of Participants With Objective Response Prior to First Local Therapy Assessed by RECIST v1.0 Criteria | Bevacizumab + Chemotherapy | 54.0 | 95% Confidence Interval 40.94 to 66.61 | percentage of participants | |
| Percentage of Participants Who Experienced EFS Events Among Participants Who Had Objective Response | Chemotherapy | 40.7 | percentage of participants | ||
| Percentage of Participants Who Experienced EFS Events Among Participants Who Had Objective Response | Bevacizumab + Chemotherapy | 76.5 | percentage of participants | ||
| Duration of Response | Chemotherapy | NA | 95% Confidence Interval 10.18 to NA | months | |
| Duration of Response | Bevacizumab + Chemotherapy | 17.48 | 95% Confidence Interval 12.29 to 25.23 | months | |
| Percentage of Participants Who Died | Chemotherapy | 50 | percentage of participants | ||
| Percentage of Participants Who Died | Bevacizumab + Chemotherapy | 51.4 | percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemotherapy | 80 | |
| Overall Study | STARTED | Bevacizumab + Chemotherapy | 74 | |
| Overall Study | COMPLETED | Chemotherapy | 7 | |
| Overall Study | COMPLETED | Bevacizumab + Chemotherapy | 7 | |
| Overall Study | NOT COMPLETED | Chemotherapy | 73 | |
| Overall Study | NOT COMPLETED | Bevacizumab + Chemotherapy | 67 |
Source ClinicalTrials.gov
Adverse events422
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 | Anaemia | Blood and lymphatic system disorders | Chemotherapy | 50 | 79 | |
| other | Anaemia | Blood and lymphatic system disorders | Bevacizumab + Chemotherapy | 55 | 71 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Chemotherapy | 14 | 79 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Bevacizumab + Chemotherapy | 12 | 71 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy | 11 | 79 | |
| other | Leukopenia | Blood and lymphatic system disorders | Bevacizumab + Chemotherapy | 13 | 71 | |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy | 53 | 79 | |
| other | Neutropenia | Blood and lymphatic system disorders | Bevacizumab + Chemotherapy | 56 | 71 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chemotherapy | 37 | 79 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bevacizumab + Chemotherapy | 31 | 71 |
1 to 10 of 422Source ClinicalTrials.gov
See all 422 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy | 40 | 79 |
| Total, all-cause mortality | Bevacizumab + Chemotherapy | 37 | 71 |
| Total, other adverse events | Chemotherapy | 78 | 79 |
| Total, other adverse events | Bevacizumab + Chemotherapy | 71 | 71 |
| Total, serious adverse events | Chemotherapy | 68 | 79 |
| Total, serious adverse events | Bevacizumab + Chemotherapy | 66 | 71 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Chemotherapy vs Bevacizumab + Chemotherapy: deaths from any cause | Trial comparisons |
| Chemotherapy vs Bevacizumab + Chemotherapy: 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/NCT00643565
GET https://conductscience.org/api/trials/v1/NCT00643565/events?page=2