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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
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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
Glioblastoma Procedure: Primary surgical treatment Radiation: Radiotherapy Drug: Temozolomide

Study Design
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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

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients
Patients with newly diagnosed and operated glioblastoma multiforme.
 Procedure: Primary surgical treatment
Primary surgery for tumor resection.
Other Names:
  • Resection
  • Operation
  • Surgery

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

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:
  • Temodal
  • Temodar
  • SCH 052365


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704808     History of Changes
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:
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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