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

Glioblastoma Clinical Trial

Official title:

Temodal (TMZ) in Concomitant Radiochemotherapy Followed by Sequential TMZ Chemotherapy in Newly Diagnosed Glioblastoma Multiforme Patients - an Observational Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725010
• Other study ID #: P04816
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: September 8, 2015
• Start date: April 2007
• Est. completion date: April 2009

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: No Health Authority approval required according to local law.
• Study type: Observational

Clinical Trial 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.

Description:

Participant sampling method: consecutive patient sampling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Number of Adverse Events in the Indicated Categories		Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase	Yes
Primary	Number of Participants Who Discontinued Due to Toxicity		Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase	Yes