Trial · NCT00626990
Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)
NCT00626990, Phase 3, Active not recruiting, European Organisation for Research and Treatment of Cancer - EORTC; results first posted 2023-09-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH). Trials, record NCT00626990. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00626990
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)
- NCT number
- NCT00626990
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 751 participants, actual
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- temozolomide, DNA methylation analysis, laboratory biomarker analysis, adjuvant therapy, quality-of-life assessment, radiation therapy
- First posted
- 2008-02-29
- Last updated
- 2023-09-11
- Other registries' IDs
- eudract:2006-001533-17
- Results first posted
- 2023-09-11
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival as Measured From the Day of Randomization | from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study) | The duration of survival is the time interval between randomization and the date of death due to any cause. Patients not reported dead or lost to follow up will be censored at the date of the last follow up examination. |
| Secondary | Progression-free Survival | from randomization till the date of disease progression or death (time till death is up to 10.9 years after patient enrollment in the study) | Disease progression is defined as radiological or neurological/clinical progression (whichever occurs first); progression free survival (PFS) is the time interval between the date of randomization and the date of disease progression or death whichever occurs first. If neither event has been observed, the patient is censored at the date of the last follow up examination. Radiological progression was defined as increase of contrast enhancing area on MRI or CT scans of more than 25% as measured by two perpendicular diameters compared to the smallest measurements ever recorded for the same lesion by the same technique. The appearance of new lesions with or without contrast enhancement Neurological/clinical progression was defined as:decrease in WHO performance status,deterioration of neurological functions,appearance of signs/symptoms of increased intracranial pressure,and/or start of corticosteroid or increase of corticosteroid dosage by 50% for control of neurological symptoms. |
| Secondary | Quality of Life of the Patient | from 14 days prior to randomization till five years or death (time till death is up to 10.9 years after patient enrollment in the study) | Quality of life was assessed by the EORTC Quality of Life Questionnaire (QLQ-C30) version 3 and the Brain Cancer Module-20 |
| Secondary | Neurological Deterioration Free Survival | within 2 weeks of randomization; during radiotherapy at week 4 and 6; 4 weeks after the end of radiotherapy; Six monthly after the end of radiotherapy; Prior to each cycle of adjuvant therapy; Every six months after the documentation of first progression. | Neurological deterioration is defined as a decrease in WHO performance status as follows: decrease in WHO performance status * for patients with baseline WHO performance status 0: deterioration to WHO performance status 2 or worse for which no other explanation is present, and which is maintained for at least three months * for patients with baseline WHO performance status 1 or 2: deterioration to WHO performance status 3 or worse for which no other explanation is present and which is maintained for at least three months The date of neurological deterioration will be the first date the persistent decrease in performance status was diagnosed. Neurological deterioration free progression is the time interval between the date of randomization and the date of neurological deterioration or death whichever occurs first. If neither event has been observed, the patient is censored at the date of the last follow up examination |
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 | Overall Survival as Measured From the Day of Randomization | from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study) | This trial studied 2 questions 1) effect of concomitant Temozolomide (TMZ) 2) effect of adjuvant TMZ. The 4 randomized arms were combined. Absence of concomitant TMZ including Arm Radiotherapy (RT) alone \& Arm RT followed by adjuvant TMZ. Presence of concomitant TMZ including Arm TMZ/RT \& Arm TMZ/RT followed by adjuvant TMZ. Absence of adjuvant TMZ including Arm RT alone \& Arm TMZ/RT. Presence of adjuvant TMZ including Arm RT followed by adjuvant TMZ \& Arm TMZ/RT followed by adjuvant TMZ | Months | MEDIAN |
| SECONDARY | Progression-free Survival | from randomization till the date of disease progression or death (time till death is up to 10.9 years after patient enrollment in the study) | This trial studied separately two questions 1) effect of concomitant TMZ 2) effect of adjuvant TMZ. The 4 randomized arms were combined before analysis. Absence of concomitant TMZ including Arm RT alone \& Arm RT followed by adjuvant TMZ. Presence of concomitant TMZ including Arm TMZ/RT \& Arm TMZ/RT followed by adjuvant TMZ. Absence of adjuvant TMZ including Arm RT alone \& Arm TMZ/RT. Presence of adjuvant TMZ including Arm RT followed by adjuvant TMZ \& Arm TMZ/RT followed by adjuvant TMZ | Months | MEDIAN |
| SECONDARY | Quality of Life of the Patient | from 14 days prior to randomization till five years or death (time till death is up to 10.9 years after patient enrollment in the study) | |||
| SECONDARY | Neurological Deterioration Free Survival | within 2 weeks of randomization; during radiotherapy at week 4 and 6; 4 weeks after the end of radiotherapy; Six monthly after the end of radiotherapy; Prior to each cycle of adjuvant therapy; Every six months after the documentation of first progression. |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival as Measured From the Day of Randomization | Absence of Concomitant Temozolomide (TMZ) | 60.42 | 95% Confidence Interval 45.7 to 71.49 | Months | |
| Overall Survival as Measured From the Day of Randomization | Presence of Concomitant Temozolomide (TMZ) | 66.92 | 95% Confidence Interval 48.53 to 82.33 | Months | |
| Overall Survival as Measured From the Day of Randomization | Absence of Adjuvant Temozolomide (TMZ) | 46.92 | 95% Confidence Interval 37.88 to 56.94 | Months | |
| Overall Survival as Measured From the Day of Randomization | Presence of Adjuvant Temozolomide (TMZ) | 82.33 | 95% Confidence Interval 67.19 to 116.63 | Months | |
| Progression-free Survival | Absence of Concomitant TMZ | 20.9 | 95% Confidence Interval 17.25 to 26.64 | Months | |
| Progression-free Survival | Presence of Concomitant TMZ | 33.02 | 95% Confidence Interval 23.82 to 46.06 | Months | |
| Progression-free Survival | Absence of Adjuvant TMZ | 19.09 | 95% Confidence Interval 14.59 to 23.82 | Months | |
| Progression-free Survival | Presence of Adjuvant TMZ | 42.81 | 95% Confidence Interval 27.83 to 56.44 | Months |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RT Alone | 189 | |
| Overall Study | STARTED | RT & Concurrent CT | 188 | |
| Overall Study | STARTED | RT + Adjuvant CT | 186 | |
| Overall Study | STARTED | RT & Concurrent CT + Adjuvant CT | 188 | |
| Overall Study | COMPLETED | RT Alone | 175 | |
| Overall Study | COMPLETED | RT & Concurrent CT | 163 | |
| Overall Study | COMPLETED | RT + Adjuvant CT | 109 | |
| Overall Study | COMPLETED | RT & Concurrent CT + Adjuvant CT | 93 | |
| Overall Study | NOT COMPLETED | RT Alone | 14 | |
| Overall Study | NOT COMPLETED | RT & Concurrent CT | 25 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events148
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 | VASCULAR | Vascular disorders | RT Alone | 2 | 186 | |
| other | VASCULAR | Vascular disorders | RT & Concurrent CT | 7 | 185 | |
| other | VASCULAR | Vascular disorders | RT + Adjuvant CT | 5 | 183 | |
| other | VASCULAR | Vascular disorders | RT & Concurrent CT + Adjuvant CT | 7 | 185 | |
| other | SURGERY/INTRA-OPERATIVE INJURY | Surgical and medical procedures | RT Alone | 0 | 186 | |
| other | SURGERY/INTRA-OPERATIVE INJURY | Surgical and medical procedures | RT & Concurrent CT | 0 | 185 | |
| other | SURGERY/INTRA-OPERATIVE INJURY | Surgical and medical procedures | RT + Adjuvant CT | 0 | 183 | |
| other | SURGERY/INTRA-OPERATIVE INJURY | Surgical and medical procedures | RT & Concurrent CT + Adjuvant CT | 0 | 185 | |
| other | ALLERGY/IMMUNOLOGY | Immune system disorders | RT Alone | 7 | 186 | |
| other | ALLERGY/IMMUNOLOGY | Immune system disorders | RT & Concurrent CT | 9 | 185 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RT Alone | 107 | 189 |
| Total, all-cause mortality | RT & Concurrent CT | 97 | 188 |
| Total, all-cause mortality | RT + Adjuvant CT | 78 | 186 |
| Total, all-cause mortality | RT & Concurrent CT + Adjuvant CT | 74 | 188 |
| Total, other adverse events | RT Alone | 182 | 186 |
| Total, other adverse events | RT & Concurrent CT | 183 | 185 |
| Total, other adverse events | RT + Adjuvant CT | 182 | 183 |
| Total, other adverse events | RT & Concurrent CT + Adjuvant CT | 185 | 185 |
| Total, serious adverse events | RT Alone | 13 | 186 |
| Total, serious adverse events | RT & Concurrent CT | 27 | 185 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
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 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/NCT00626990
GET https://conductscience.org/api/trials/v1/NCT00626990/events?page=2