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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00704808
First received: June 23, 2008
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Glioblastoma
Procedure: Primary surgical treatment
Radiation: Radiotherapy
Drug: Temozolomide

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: May 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704808     History of Changes
Other Study ID Numbers: P04739
Study First Received: June 23, 2008
Results First Received: March 17, 2010
Last Updated: April 29, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014