Trial · NCT00689221
Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Methylated Gene Promoter Status
NCT00689221, Phase 3, Completed, EMD Serono; results first posted 2014-11-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Methylated Gene Promoter Status. Trials, record NCT00689221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00689221
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Methylated Gene Promoter Status
- NCT number
- NCT00689221
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 545 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Glioblastoma
- Interventions
- Cilengitide, Temozolomide, Radiotherapy
- First posted
- 2008-06-03
- Last updated
- 2014-11-04
- Other registries' IDs
- eudract:2007-004344-78
- Results first posted
- 2014-11-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) Time | Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012) | The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. |
| Secondary | Progression Free Survival (PFS) Time - Investigator and Independent Read | Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012) | The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site and Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC). Investigator's assessed progression according to MacDonald criteria and IRC by Response Assessment in Neuro-Oncology Working Group (RANO) criteria using Gadolinium-enhanced magnetic resonance imaging. Investigator and IRC read: Progression is defined as greater than 25 percent increase in the sum of the product of the largest perpendicular diameters of enhancing tumor compared to the smallest prior sum, or Worsening of an evaluable lesion(s),or Marked increase in T2/FLAIR non-enhancing lesions (IRC only) or Any new lesion |
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Day 1 of Week -1 | The Cmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1. |
| Secondary | Time to Maximum Plasma Concentration (Tmax) | Day 1 of Week -1 | The Tmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1. |
| Secondary | Area Under the Plasma Concentration Curve From Time 0 to 6 Hours (AUC [0-6]) After Dose | Day 1 of Week -1 | The AUC (0-6) for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1. |
| Secondary | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Sub-scale Scores | Up to 50 months | The EORTC QLQ-C30 is a questionnaire including following sub-scales: global health status, functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social activity), symptom scales (fatigue, nausea and vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties). Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better quality of life on global health status and functional scales and worse quality of life on symptom scales and financial difficulty scale. |
| Secondary | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Brain Module (EORTC QLQ-BN20) Sub-scale Scores | Up to 50 months | The QLQ-BN20 is a questionnaire specifically designed as the QLQ-C30 supplement for the evaluation of quality of life in brain tumor participants. It includes 4 multi-item sub-scales: future uncertainty, visual disorder, motor dysfunction, communication deficits, and 7 single-item scales: headaches, seizures, drowsiness, itchy skin, hair loss, weakness of legs, and bladder control. All items are rated on a 4-point Likert-type scale ('1=not at all', '2=a little', '3=quite a bit' and '4=very much'), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms. |
| Secondary | EuroQol 5-Dimensions (EQ-5D) Questionnaire Index | Up to 50 months | The EuroQuol-5D (EQ-5D) questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.594 (death) and the highest is 1.00 (full health). |
| Secondary | Number of Participants With Change From Baseline in Work Status at End of Study | Baseline, End of study (up to cut-off date, [19 Nov 2012]) | Number of participants with change from baseline in work status (working full time \[FT\], part-time \[PT\], unemployed/retired \[U/R\]) at end of study (EOS) (up to cut-off date, \[19 Nov 2012\]) was reported. For the category 'part-time', the following sub-categories were defined: part-time due to basic disease (PT1); part-time not due to basic disease (PT2); part-time reason not known (PT3). |
| Secondary | Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment Related AEs of Grade 3 or 4 | Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012) | An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Treatment-emergent AEs are the events between first dose of study drug and up to 28 days after last dose of study treatment. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-related AEs are the AEs which are suspected to be reasonably related to the study treatment (cilengitide, or radiotherapy, or temozolomide) as per investigator assessment. The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) Time | Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012) | ITT population included all the participants who were randomized to study treatment. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Time - Investigator and Independent Read | Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012) | ITT population included all the participants who were randomized to study treatment. | Months | MEDIAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) | Day 1 of Week -1 | Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1. | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Time to Maximum Plasma Concentration (Tmax) | Day 1 of Week -1 | Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1. | hours | MEAN |
| SECONDARY | Area Under the Plasma Concentration Curve From Time 0 to 6 Hours (AUC [0-6]) After Dose | Day 1 of Week -1 | Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | hour*ng/mL | MEAN |
| SECONDARY | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Sub-scale Scores | Up to 50 months | ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category. | units on a scale | MEAN |
| SECONDARY | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Brain Module (EORTC QLQ-BN20) Sub-scale Scores | Up to 50 months | ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category. | units on a scale | MEAN |
| SECONDARY | EuroQol 5-Dimensions (EQ-5D) Questionnaire Index | Up to 50 months | ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Change From Baseline in Work Status at End of Study | Baseline, End of study (up to cut-off date, [19 Nov 2012]) | Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period. | participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment Related AEs of Grade 3 or 4 | Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012) | Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period. | Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group145
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) Time | Cilengitide + Temozolomide + Radiotherapy | 26.3 | 95% Confidence Interval 23.8 to 28.8 | Months | |
| Overall Survival (OS) Time | Temozolomide + Radiotherapy | 26.3 | 95% Confidence Interval 23.9 to 34.7 | Months | |
| Progression Free Survival (PFS) Time - Investigator and Independent Read | Cilengitide + Temozolomide + Radiotherapy | PFS Time: Investigator read | 13.5 | 95% Confidence Interval 10.8 to 15.9 | Months |
| Progression Free Survival (PFS) Time - Investigator and Independent Read | Temozolomide + Radiotherapy | PFS Time: Investigator read | 10.7 | 95% Confidence Interval 8.1 to 13.3 | Months |
| Progression Free Survival (PFS) Time - Investigator and Independent Read | Cilengitide + Temozolomide + Radiotherapy | PFS Time: Independent read | 10.6 | 95% Confidence Interval 8.2 to 13.4 | Months |
| Progression Free Survival (PFS) Time - Investigator and Independent Read | Temozolomide + Radiotherapy | PFS Time: Independent read | 7.9 | 95% Confidence Interval 5.9 to 12.5 | Months |
| Maximum Observed Plasma Concentration (Cmax) | Cilengitide + Temozolomide + Radiotherapy | 167363.2 | Standard Deviation 368301.11 | nanogram per milliliter (ng/mL) | |
| Time to Maximum Plasma Concentration (Tmax) | Cilengitide + Temozolomide + Radiotherapy | 1.029 | Standard Deviation 0.401 | hours | |
| Area Under the Plasma Concentration Curve From Time 0 to 6 Hours (AUC [0-6]) After Dose | Cilengitide + Temozolomide + Radiotherapy | 295171.2 | Standard Deviation 198050.62 | hour*ng/mL | |
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Sub-scale Scores | Cilengitide + Temozolomide + Radiotherapy | Global Health Status (n=71, 92) | 54.34 | Standard Deviation 25.58 | units on a scale |
1 to 10 of 145Source ClinicalTrials.gov
See all 145 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cilengitide + Temozolomide + Radiotherapy | 272 | |
| Overall Study | STARTED | Temozolomide + Radiotherapy | 273 | |
| Overall Study | COMPLETED | Cilengitide + Temozolomide + Radiotherapy | 233 | |
| Overall Study | COMPLETED | Temozolomide + Radiotherapy | 237 | |
| Overall Study | NOT COMPLETED | Cilengitide + Temozolomide + Radiotherapy | 39 | |
| Overall Study | NOT COMPLETED | Temozolomide + Radiotherapy | 36 |
Source ClinicalTrials.gov
Adverse events490
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 | NAUSEA | Gastrointestinal disorders | Cilengitide + Temozolomide + Radiotherapy | 128 | 263 | |
| other | NAUSEA | Gastrointestinal disorders | Temozolomide + Radiotherapy | 125 | 258 | |
| other | CONSTIPATION | Gastrointestinal disorders | Cilengitide + Temozolomide + Radiotherapy | 100 | 263 | |
| other | CONSTIPATION | Gastrointestinal disorders | Temozolomide + Radiotherapy | 78 | 258 | |
| other | VOMITING | Gastrointestinal disorders | Cilengitide + Temozolomide + Radiotherapy | 77 | 263 | |
| other | VOMITING | Gastrointestinal disorders | Temozolomide + Radiotherapy | 83 | 258 | |
| other | DIARRHOEA | Gastrointestinal disorders | Cilengitide + Temozolomide + Radiotherapy | 44 | 263 | |
| other | DIARRHOEA | Gastrointestinal disorders | Temozolomide + Radiotherapy | 20 | 258 | |
| other | DYSPEPSIA | Gastrointestinal disorders | Cilengitide + Temozolomide + Radiotherapy | 24 | 263 | |
| other | DYSPEPSIA | Gastrointestinal disorders | Temozolomide + Radiotherapy | 8 | 258 |
1 to 10 of 490Source ClinicalTrials.gov
See all 490 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cilengitide + Temozolomide + Radiotherapy | ||
| Total, all-cause mortality | Temozolomide + Radiotherapy | ||
| Total, other adverse events | Cilengitide + Temozolomide + Radiotherapy | 251 | 263 |
| Total, other adverse events | Temozolomide + Radiotherapy | 240 | 258 |
| Total, serious adverse events | Cilengitide + Temozolomide + Radiotherapy | 138 | 263 |
| Total, serious adverse events | Temozolomide + Radiotherapy | 115 | 258 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cilengitide + Temozolomide + Radiotherapy vs Temozolomide + Radiotherapy: serious adverse events |
Source 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/NCT00689221
GET https://conductscience.org/api/trials/v1/NCT00689221/results?page=2