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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
  Purpose

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


Condition Intervention Phase
Glioblastoma
 Drug: TMZ
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • safety and efficacy [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 1153
Study Start Date: January 2007
Study Completion Date: June 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
TMZ d 1-5 of 28-d cycle 6 cycles
 Drug: TMZ
Comparing conventional adjuvant Temozolomide with dose intensive Temozolomide
Other Name: TMZ
Experimental: 2
TMZ d 1-21 of 28-d cycle 6 cycles
 Drug: TMZ
Comparing conventional adjuvant Temozolomide with dose intensive Temozolomide
Other Name: TMZ

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Newly Diagnosed Glioblastoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364064

Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Naseer Al-Rajhi KFSH & RC
  More Information

No publications provided

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT01364064     History of Changes
Other Study ID Numbers: RAC#2081-018
Study First Received: May 31, 2011
Last Updated: May 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013