Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)

Glioblastoma Clinical Trial

Official title:

Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704808
• Other study ID #: P04739
• Status: Completed
• Phase: N/A
• First received: June 23, 2008
• Last updated: September 8, 2015
• Start date: May 2006
• Est. completion date: December 2008

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have newly diagnosed and operated glioblastoma multiforme with postoperative residual tumor <=1.5 cm by magnetic resonance imaging (MRI).

• Age >=18 years.

• Hemoglobin >=10 g/dL.

• White blood cell count >=1.5x10^9/L.

• Platelet count >=100x10^9/L.

• Blood urea <=1.5 x upper limit of normal values (ULN).

• Creatinine <=1.5 x ULN.

• Bilirubin <=1.5 x ULN.

• Aspartate aminotransferase <=3 x ULN.

• Alanine aminotransferase <=3 x ULN.

• Alkaline phosphatase <=2 x ULN.

Exclusion Criteria:

• Tumor-specific pretreatment.

• Contraindication against radiotherapy and/or chemotherapy.

• Malignomas other than basaliomas.

• Existing or planned pregnancy or lactation or inadequate contraception.

• Psychiatric disease.

• Simultaneous participation in another clinical trail or participation in another clinical trail in the last 30 days before recruitment.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Procedure:
• Primary surgical treatment
Primary surgery for tumor resection.

Radiation:
• Radiotherapy
Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics.

Drug:
• Temozolomide
Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics.

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	Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme		After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide	No