Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)
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ClinicalTrials.gov Identifier: NCT00704808 |
Recruitment Status :
Completed
First Posted : June 25, 2008
Results First Posted : April 2, 2010
Last Update Posted : September 9, 2015
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Brief Summary:
The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.
Condition or disease | Intervention/treatment |
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Glioblastoma | Procedure: Primary surgical treatment Radiation: Radiotherapy Drug: Temozolomide |
Study Type : | Observational |
Actual Enrollment : | 180 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |
Resource links provided by the National Library of Medicine

Drug Information available for:
Temozolomide
Group/Cohort | Intervention/treatment |
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Patients
Patients with newly diagnosed and operated glioblastoma multiforme.
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Procedure: Primary surgical treatment
Primary surgery for tumor resection.
Other Names:
Radiation: Radiotherapy Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics.
Other Names:
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:
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Primary Outcome Measures :
- 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 ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Study Population
Patients with newly diagnosed glioblastoma multiforme.
Criteria
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.
No Contacts or Locations Provided
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00704808 |
Other Study ID Numbers: |
P04739 |
First Posted: | June 25, 2008 Key Record Dates |
Results First Posted: | April 2, 2010 |
Last Update Posted: | September 9, 2015 |
Last Verified: | September 2015 |
Additional relevant MeSH terms:
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |