PMS: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739) - Full Text View

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

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Temozolomide

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

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

Further study details as provided by Schering-Plough:

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: 3 months, 6 months, 9 months, and 12 months after start of treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of toxicity (per National Cancer Institute Common Toxicity Criteria) [ Time Frame: 3 months, 6 months, 9 months, and 12 months after start of treatment. ] [ Designated as safety issue: Yes ]
Progression free survival [ Time Frame: 3 months, 6 months, 9 months, and 12 months after start of treatment. ] [ Designated as safety issue: No ]
Determination of overall survival [ Time Frame: One year from end of treatment. ] [ Designated as safety issue: No ]
Karnofsky performance status [ Time Frame: One year from end of treatment. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	180
Study Start Date:	April 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (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.

Radiation: Radiotherapy

Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics.

Drug: Temozolomide

Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics.

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

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04739
First Received:	June 23, 2008
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00704808
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Neuroectodermal Tumors

Glioblastoma

Glioblastoma multiforme

Astrocytoma

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Glioma

Temozolomide

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Neoplasms, Nerve Tissue

Antineoplastic Agents, Alkylating

Neoplasms, Neuroepithelial

Alkylating Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00704808