Conventional Adjuvant Temozolomide With Dose Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

King Faisal Specialist Hospital & Research Center

ClinicalTrials.gov Identifier:

NCT01364064

First received: May 31, 2011

Last updated: May 26, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 31, 2011

Last Updated Date

May 26, 2012

Start Date ^ICMJE

January 2007

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

safety and efficacy [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01364064 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Conventional Adjuvant Temozolomide With Dose Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma

Official Title ^ICMJE

Not Provided

Brief Summary

This is a Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose Intensive Temozolomide in Patients with Newly Diagnosed Glioblastoma.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Glioblastoma

Intervention ^ICMJE

Drug: TMZ

Comparing conventional adjuvant Temozolomide with dose intensive Temozolomide

Other Name: TMZ

Study Arm (s)

Active Comparator: 1
TMZ d 1-5 of 28-d cycle 6 cycles

Intervention: Drug: TMZ
Experimental: 2
TMZ d 1-21 of 28-d cycle 6 cycles

Intervention: Drug: TMZ

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1153

Completion Date

June 2009

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with Newly Diagnosed Glioblastoma

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01364064

Other Study ID Numbers ^ICMJE

RAC#2081-018

Has Data Monitoring Committee

Yes

Responsible Party

King Faisal Specialist Hospital & Research Center

Study Sponsor ^ICMJE

King Faisal Specialist Hospital & Research Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Naseer Al-Rajhi

KFSH & RC

Information Provided By

King Faisal Specialist Hospital & Research Center

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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