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

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: October 31, 2014

Last verified: October 2014

History of Changes

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:

Drug Information available for: Temozolomide

Genetic and Rare Diseases Information Center resources: Anaplastic Astrocytoma Glioblastoma Glioma Gliosarcoma Neuroepithelioma

U.S. FDA Resources

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

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:	October 31, 2014
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:


Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial	Neuroectodermal Tumors Temozolomide Alkylating Agents Antineoplastic Agents Antineoplastic Agents, Alkylating Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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