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

September 8, 2015 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with newly diagnosed glioblastoma multiforme.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients with newly diagnosed and operated glioblastoma multiforme.
Procedure: Primary surgical treatment
Primary surgery for tumor resection.
Other Names:
  • Operation
  • Surgery
  • Resection
Radiation: Radiotherapy
Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics.
Other Names:
  • Radiation therapy
  • Irradiation
Drug: Temozolomide
Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics.
Other Names:
  • Temodar
  • Temodal
  • SCH 052365

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme
Time Frame: After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide
After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (Estimate)

June 25, 2008

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 8, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04739

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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