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Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 30, 2008
Last Update Posted: September 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a routine care setting.

Condition Intervention
Glioblastoma Drug: Temozolomide Radiation: Radiotherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Temodal (TMZ) in Concomitant Radiochemotherapy Followed by Sequential TMZ Chemotherapy in Newly Diagnosed Glioblastoma Multiforme Patients - an Observational Program

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Safety: Number of Adverse Events in the Indicated Categories [ Time Frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase ]
  • Number of Participants Who Discontinued Due to Toxicity [ Time Frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase ]

Enrollment: 64
Study Start Date: April 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants with newly diagnosed Glioblastoma multiforme who were prescribed temozolomide and radiotherapy as standard care.
Drug: Temozolomide
Temozolomide will be administered orally at 75 mg/m^2 with radiotherapy during the concomitant treatment phase. After four weeks, temozolomide will be administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase.
Other Names:
  • Temodal
  • Temodar
  • SCH 052365
Radiation: Radiotherapy
Radiotherapy will consist of fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
Other Names:
  • Radiation therapy
  • Irradiation

Detailed Description:
Participant sampling method: consecutive patient sampling.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with newly diagnosed Glioblastoma multiforme

Inclusion Criteria:

  • Newly diagnosed Glioblastoma multiforme

Exclusion Criteria:

  • History of hypersensitivity to temozolomide or its components, or to dacarbazine.
  • Women who are pregnant or breast-feeding.
  • Patients with severe myelosuppression.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725010     History of Changes
Other Study ID Numbers: P04816
First Submitted: July 25, 2008
First Posted: July 30, 2008
Results First Submitted: October 22, 2010
Results First Posted: November 18, 2010
Last Update Posted: September 9, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents