Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)
Temodal (TMZ) in Concomitant Radiochemotherapy Followed by Sequential TMZ Chemotherapy in Newly Diagnosed Glioblastoma Multiforme Patients - an Observational Program
1 other identifier
observational
64
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
November 18, 2010
CompletedSeptember 9, 2015
September 1, 2015
2 years
July 25, 2008
October 22, 2010
September 8, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Safety: Number of Adverse Events in the Indicated Categories
Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase
Number of Participants Who Discontinued Due to Toxicity
Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase
Study Arms (1)
Patients
Participants with newly diagnosed Glioblastoma multiforme who were prescribed temozolomide and radiotherapy as standard care.
Interventions
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.
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.
Eligibility Criteria
Subjects with newly diagnosed Glioblastoma multiforme
You may qualify if:
- Newly diagnosed Glioblastoma multiforme
You may not qualify if:
- History of hypersensitivity to temozolomide or its components, or to dacarbazine.
- Women who are pregnant or breast-feeding.
- Patients with severe myelosuppression.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 30, 2008
Study Start
April 1, 2007
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
September 9, 2015
Results First Posted
November 18, 2010
Record last verified: 2015-09