Trial · NCT00200161

Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma

NCT00200161, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2018-03-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma. Trials, record NCT00200161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00200161

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma
NCT number: NCT00200161
Status: Completed
Phases: Phase 2
Enrollment: 127 participants, actual
Lead sponsor: Memorial Sloan Kettering Cancer Center
Conditions: Glioblastoma, Gliomas
Interventions: Temozolomide, Temozolomide
First posted: 2005-09-20
Last updated: 2018-03-07
Results first posted: 2018-03-07

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	12 Month Overall Survival of Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concurrent Temozolomide and Radiotherapy Followed by Dose Dense or Metronomic Dosing of Temozolomide and Maintenance Cis-retinoic Acid.	until death or date of last follow up, an average of 12 months
Secondary	Progression Free Survival at 6 Months	6 months
Secondary	Prognostic Impact of Methylated MGMT Status.	through study completion, an average of 1 year	MGMT promoter methylation is currently considered the main prognostic biomarker in glioblastoma. Methylation MGMT status will be assessed using real-time PCR.
Secondary	To Collect Preliminary Data on the Efficacy of This Regimen and Impact of MGMT Status in Other Malignant Glioma Subtypes.	through study completion, an average of 1 year

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	12 Month Overall Survival of Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concurrent Temozolomide and Radiotherapy Followed by Dose Dense or Metronomic Dosing of Temozolomide and Maintenance Cis-retinoic Acid.	until death or date of last follow up, an average of 12 months		percentage of participants	NUMBER
SECONDARY	Progression Free Survival at 6 Months	6 months		percentage of participants	NUMBER
SECONDARY	Prognostic Impact of Methylated MGMT Status.	through study completion, an average of 1 year	Data were not collected
SECONDARY	To Collect Preliminary Data on the Efficacy of This Regimen and Impact of MGMT Status in Other Malignant Glioma Subtypes.	through study completion, an average of 1 year	Data were not collected

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
12 Month Overall Survival of Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concurrent Temozolomide and Radiotherapy Followed by Dose Dense or Metronomic Dosing of Temozolomide and Maintenance Cis-retinoic Acid.	Metronomic Therapy Cohort	69	percentage of participants
12 Month Overall Survival of Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concurrent Temozolomide and Radiotherapy Followed by Dose Dense or Metronomic Dosing of Temozolomide and Maintenance Cis-retinoic Acid.	Dose-Dense Therapy Cohort	80	percentage of participants
Progression Free Survival at 6 Months	Metronomic Therapy Cohort	46	percentage of participants
Progression Free Survival at 6 Months	Dose-Dense Therapy Cohort	56	percentage of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Metronomic Therapy Cohort	43
Overall Study	STARTED	Dose-Dense Therapy Cohort	42
Overall Study	COMPLETED	Metronomic Therapy Cohort	43
Overall Study	COMPLETED	Dose-Dense Therapy Cohort	42
Overall Study	NOT COMPLETED	Metronomic Therapy Cohort	0
Overall Study	NOT COMPLETED	Dose-Dense Therapy Cohort	0

Source ClinicalTrials.gov

Adverse events90

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
other	Bilirubin	Investigations	Metronomic Therapy Cohort	22	43
other	Bilirubin	Investigations	Dose-Dense Therapy Cohort	18	42
other	Hyperglycemia	Metabolism and nutrition disorders	Metronomic Therapy Cohort	34	43
other	Hyperglycemia	Metabolism and nutrition disorders	Dose-Dense Therapy Cohort	32	42
other	Alkaline Phosphatase	Investigations	Metronomic Therapy Cohort	10	43
other	Alkaline Phosphatase	Investigations	Dose-Dense Therapy Cohort	8	42
other	ALT	Investigations	Metronomic Therapy Cohort	43	43
other	ALT	Investigations	Dose-Dense Therapy Cohort	36	42
other	Lymphopenia	Investigations	Metronomic Therapy Cohort	30	43
other	Lymphopenia	Investigations	Dose-Dense Therapy Cohort	27	42

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metronomic Therapy Cohort	0	43
Total, all-cause mortality	Dose-Dense Therapy Cohort	1	42
Total, other adverse events	Metronomic Therapy Cohort	43	43
Total, other adverse events	Dose-Dense Therapy Cohort	42	42
Total, serious adverse events	Metronomic Therapy Cohort	0	43
Total, serious adverse events	Dose-Dense Therapy Cohort	0	42

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Metronomic Therapy Cohort vs Dose-Dense Therapy Cohort: deaths from any cause	Trial comparisons
Metronomic Therapy Cohort vs Dose-Dense Therapy Cohort: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00200161

GET https://conductscience.org/api/trials/v1/NCT00200161/events?page=2

API reference For AI assistants